BD (Becton, Dickinson) Global Medical Device Registrations Dossier

A global registry dossier for Becton, Dickinson and Company (BD), analyzing medical device registrations across 25 non-US markets and the integration of CareFusion and C.R. Bard.

Global Regulatory Dossier: BD (Becton, Dickinson and Company)

For regulatory affairs teams, market-access managers, and competitive intelligence analysts, understanding the global regulatory footprint of Becton, Dickinson and Company (BD) is key. As one of the largest medical technology companies in the world, BD's product portfolio is massive, spanning medical devices, laboratory equipment, diagnostic reagents, and software-as-a-medical-device (SaMD) solutions.

This global data dossier analyzes the distribution of BD’s product registrations across major international medical device databases. By compiling data from 34 national and regional registries across six continents, we examine where BD holds active registrations, how its historical acquisitions—specifically CareFusion (acquired in 2015) and C.R. Bard (acquired in 2017)—are integrated into global databases, and the differences between its product approvals and local channel configurations.

Scenario Question & Direct Answer

How is BD's global medical device footprint distributed across major world markets, and how do its legacy acquisitions (CareFusion, C.R. Bard) affect international registrations?

Global medical device registration databases confirm BD's vast global manufacturing and regulatory footprint, showing positive manufacturer-level matches in 25 non-US markets. This includes 659 active licenses in Canada MDALL, 433 in Australia ARTG, 428 in Brazil ANVISA, 1,734 CDSCO entries in India, and 3,327 SFDA listings in Saudi Arabia, alongside massive US FDA listings (1,967 510(k)s, 317 PMAs, and 10,773 UDI listings). The data reflects the integration of CareFusion (acquired 2015) and C.R. Bard (acquired 2017), with legacy names still holding major registry shares. Channel/distributor data shows BD operates through direct local subsidiaries in major markets (e.g. BD Colombia, BD Korea, BD Canada).

The Global Evidence Map: Positive Registry Matches

To construct a reliable map of BD's global footprint, we inspected the official device registers of major markets. The table below represents positive matches where BD or its verified subsidiaries (CareFusion, C.R. Bard, Davol, etc.) are listed as the manufacturer, sponsor, or license holder.

Jurisdiction / Market	Database Source	Active Records (Combined)	Manufacturer Entity Values Identified	Classification
United States	FDA CDRH (510k, PMA, Reg/Listing, UDI)	1,967 (510k) / 317 (PMA) / 2,586 (Reg) / 10,773 (UDI)	Becton, Dickinson and Company; Bard Peripheral Vascular; CareFusion 307; C.R. Bard Inc.	POSITIVE
European Union	EUDAMED Public Devices & Actors	84 (Devices) / 27 (Actors)	Becton, Dickinson and Company; Becton Dickinson Ireland Limited; C.R. Bard	POSITIVE
Canada	Health Canada MDALL Active Licenses	659	Becton Dickinson & Co; C.R. Bard; Bard Peripheral; BD Biosciences; CareFusion	POSITIVE
Australia	TGA Australian Register of Therapeutic Goods (ARTG)	433	Becton Dickinson Pty Ltd; CareFusion; Bard Peripheral; Davol Inc	POSITIVE
Brazil	ANVISA Medical Devices Database	428	Becton Dickinson Indústrias Cirúrgicas Ltda; Becton Dickinson & Co; C.R. Bard Inc	POSITIVE
India	CDSCO Approved Devices Register	1,734	Becton Dickinson India Pvt Ltd; C.R. Bard Inc; BD Infusion Therapy Systems	POSITIVE
Saudi Arabia	SFDA Medical Equipment List	3,327	CareFusion; Becton Dickinson & Co; BD Biosciences; Bard Peripheral; Angiomed	POSITIVE
South Korea	MFDS Device Registrations	1,305	Becton Dickinson Caribe Ltd; CareFusion; Becton Dickinson and Company; Bard	POSITIVE
Taiwan	TFDA Registered Medical Devices	830	Becton Dickinson and Company; Bard Peripheral Vascular; BD Biosciences; C.R. Bard	POSITIVE
Vietnam	MOH Approved Devices List	804	Becton Dickinson Asia Limited (Representative Office HCMC)	POSITIVE
Indonesia	Kemkes Registered Medical Devices	315	PT Becton Dickinson Indonesia; Becton Dickinson Caribe Ltd	POSITIVE
Singapore	HSA Registered Medical Devices	393	Becton Dickinson Holdings Pte Ltd; Becton, Dickinson and Company; Bard	POSITIVE
Malaysia	MDA Registered Devices	273	Becton Dickinson Sdn Bhd (Registrant & Local Representative)	POSITIVE
Mexico	COFEPRIS Health Registrations	109	Becton Dickinson de México, S.A. de C.V.	POSITIVE
United Kingdom	MHRA Active Manufacturers	33	Becton, Dickinson and Company; Becton Dickinson S.A.; Bard Peripheral Vascular	POSITIVE
Argentina	ANMAT Registered Medical Devices	54	Becton Dickinson Argentina SRL; Bard Peripheral	POSITIVE
Hong Kong	MDD Listed Medical Devices	143	Becton Dickinson Asia Limited (LRP); Bard Peripheral Vascular; CareFusion	POSITIVE
Israel	MOH Medical Device Register	319	Becton, Dickinson and Company; BD Biosciences; Bard Peripheral; CareFusion	POSITIVE
UAE	EDE Registered Medical Devices	71	Becton Dickinson S.A. (Spain); CareFusion 213; Davol; BD & Co Ireland	POSITIVE
Bahrain	NHRA Registered Medical Devices	21	Becton Dickinson Infusion Therapy Systems (Mexico/USA); BD & Co Ireland	POSITIVE
Kazakhstan	NDDA Registered Medical Devices	12	BD Vacutainer brand listings (local distributor registered)	POSITIVE
Pakistan	DRAP Registered Devices	72	Becton Dickinson & Co; Bard Peripheral; BD Diagnostics	POSITIVE
Ecuador	ARCSA Medical Devices Database	74	BD Vacutainer; Becton Dickinson; BD Biosciences; CareFusion (brand-level)	POSITIVE
Albania	AKBPM Medical Device Registry	71	Becton Dickinson & Co; Becton Dickinson GmbH; BD Plymouth	POSITIVE
Colombia	INVIMA Medical Devices Database	5,000	Becton Dickinson de Colombia Ltda; CareFusion UK; Becton Dickinson & Co	POSITIVE

Registry Limitations & No-Hit Analysis

When conducting global intelligence sweeps, identifying where a company is not present or where data is constrained is just as important as mapping positive hits. The table below outlines the databases inspected where no active product registrations were found, or where the dataset imposes significant limitations.

Jurisdiction	Database Inspected	Finding / Negative Status	Technical Caveat / Database Limitation
Switzerland	swissdamed (UDI Details)	NO-HIT	The UDI-detail snapshot (60,611 records) lacks manufacturer fields or is unpopulated in this slice. One owner found is ZimVie (dental/spine spinoff), which is unrelated to BD.
Jordan	JFDA Medical Devices List	NO-HIT	No BD or subsidiary records found across 1,849 scraped HTML pages. Represents a coverage gap or lack of public database export.
Oman	MOH Medical Devices	NO-HIT	Single HTML landing page containing no device rows; no database search capability is currently active.
Moldova	AMDM Medical Devices	NO-HIT (Limitation)	Status log only; consolidation of device records was unparseable.
Qatar	MoPH Implantable Devices	LIMITATION (1 Hit)	Scoped strictly to implantable devices (2,623 records); returned only 1 hit (Carefusion, PleurX Catheter Kit).
Ghana	FDA Product Registry	NO-HIT (Largest File)	Scoped mainly to food/drugs; only 6 hits market-wide in raw page files (in page_14000).
Nigeria	NAFDAC Greenbook	LIMITATION (Brand-level)	Scoped to page 0 only (1,119 records); matches are brand-level only (e.g., "BD Vacutainer") held by local distributors.
UK	MHRA Devices List	LIMITATION	File carries GMDN/device-type fields only, with no manufacturer-name column (only manufacturer ID). Registration data was extracted from the UK Manufacturers file.

Understanding Registry Data Limits: A Commercial Warning

A key mistake made by market analysts is treating medical device registration records as equivalent to market share, product sales, or clinical usage. It is critical to recognize the inherent limits of registry datasets:

Registrations are Not Sales: An active registration simply indicates that a device is legally cleared for commercial sale in that country. It does not mean the device is actively marketed, stocked, or utilized in local hospitals. Large manufacturers like BD frequently maintain hundreds of legacy registrations for products that are commercially inactive or have been replaced by newer generations.
Record Counts do Not Equal Unique SKUs: The unit of measurement in registries is the "record" or "line count". A single registration record can cover hundreds of individual catalog numbers (SKUs), packaging sizes, or product configurations. Conversely, a single product line might be split across multiple registration records due to manufacturing site variations or component classifications.
Vigilance and Recalls reflect Report Counts, not Safety Incidence: In public safety databases (such as the US FDA Recall and Enforcement databases, which list 1,472 and 1,054 BD-related entries respectively), counts reflect administrative actions and reporting volume. Because BD holds a vast market share in high-volume consumables (such as syringes, blood-collection tubes, and IV catheters), the sheer volume of products in circulation naturally correlates to a higher absolute number of reports, which does not represent a higher defect rate.
Distributor Lists are Channel Evidence, Not Approvals: In databases listing authorized importers or distributors, the presence of a BD entity indicates a commercial channel setup rather than a technical product approval. A local distributor must be licensed to import, but they can only import products that have separately secured technical registration certificates.

Detailed Market Profiles & Registry Insights

To understand BD's global footprint, we must look beyond numbers and inspect how BD is represented in specific key databases. Below is a detailed breakdown of the registries where BD has its most significant presence.

1. United States: FDA CDRH Database

The United States represents BD's home market and holds the largest concentration of records. By querying the FDA CDRH databases, we can see the full historical scale of BD's filings:

FDA 510(k): Out of 175,149 active and historical 510(k) records, the combined query returns 1,967 matches. The vast majority of these are held by Becton Dickinson & Co (1,142), with substantial numbers under C.R. Bard (668) and CareFusion (45). A sample record includes K231237 for BD Vacutainer Fluoride Tubes (cleared in 2024), representing its dominance in pre-analytical systems.
FDA PMA: For high-risk Class III devices, the PMA database (56,508 records) contains 317 matches. The majority of these represent legacy C.R. Bard listings, such as the P160024 LifeStream Balloon Expandable Vascular Covered Stent, reflecting Bard's historical focus on vascular and interventional medicine.
FDA Registration & Listing: Out of 417,036 registered establishments and listing records, there are 2,586 combined matches, highlighting the extensive manufacturing footprint of the group.
FDA Unique Device Identification (UDI): The Global UDI Database (GUDID), which tracks individual device models, contains 10,773 listings associated with the company, representing the vast catalog of consumables, diagnostic kits, and hardware instruments.

2. Canada: Health Canada MDALL

Health Canada's Medical Devices Active License Listing (MDALL) represents one of the cleanest product-level registries in the world. It tracks active licenses for Class II, III, and IV medical devices:

Denominator: 152,560 active license records.
Combined BD Matches: 659 active licenses.
Analysis: This register shows that C.R. Bard (164 licenses) and Bard Peripheral Vascular (97 licenses) combined exceed the core Becton Dickinson & Co (120 licenses) count. This indicates that a large share of the company's Canadian catalog consists of interventional urology, oncology, and vascular access devices acquired in the 2017 transaction.
Subsidiary Breakdown: Other active licensee entities include BD Biosciences (87), BD Infusion Therapy (41), Davol (a subsidiary of C.R. Bard, 40), and CareFusion (22).

3. Australia: TGA ARTG

The Australian Register of Therapeutic Goods (ARTG) is the repository of all medical devices approved for supply in Australia.

Denominator: 99,405 records.
Combined BD Matches: 433 sponsor or manufacturer listings.
Analysis: The database shows Becton Dickinson Pty Ltd (the local Australian subsidiary) listed as the sponsor for 216 active entries. On the manufacturing side, legacy names remain prominent: Carefusion is listed as the manufacturer for 141 listings, and Bard/Davol entities account for 99 listings.
Sample Entry: A typical listing is ARTG 107937 for BD Vacutainer blood collection tubes, with Becton Dickinson Pty Ltd as sponsor and Becton Dickinson and Company (USA) as manufacturer.

4. Brazil: ANVISA Registry

Brazil represents the largest healthcare market in Latin America and requires separate ANVISA registration for all devices.

Denominator: 111,789 active records.
Combined BD Matches: 428 registrations.
Analysis: Brazil's data is divided between the foreign manufacturer (Fabricante) and the local registration holder (Detentor). The local subsidiary, Becton Dickinson Indústrias Cirúrgicas Ltda, is listed as the detentor for 343 records, showing that BD directly owns and controls its registrations in Brazil.
Manufacturer Breakdown: The corresponding foreign manufacturers are Becton Dickinson & Co (USA), C.R. Bard Inc (USA), and BD Spain (Fraga).

5. Saudi Arabia: SFDA Medical Equipment List

The Saudi Food and Drug Authority (SFDA) operates a strict registration system that serves as a benchmark for the Middle East.

Denominator: 163,185 records.
Combined BD Matches: 3,327 records.
Analysis: Saudi Arabia represents an exceptionally high record count for BD. This is driven by CareFusion (1,173 listings) and BD Biosciences (368 listings), reflecting a high density of laboratory and infusion system components.
M&A Representation: Legacy Bard entities account for over 350 listings, including Angiomed GmbH (a German subsidiary of C.R. Bard, 113 listings).

6. India: CDSCO Approved Endpoints

India's Central Drugs Standard Control Organisation (CDSCO) is actively transition medical devices from a non-regulated status to mandatory licensing.

Denominator: 165,296 records.
Combined BD Matches: 1,734 records.
Analysis: India's registry tracks manufacturing premises and import licenses. The data lists Becton Dickinson India Private Limited (based in Chennai and Gurgaon) as the local importer and applicant, with actual manufacturing sites located in Covington, Georgia (C.R. Bard), Sandy, Utah (BD Infusion), and Sparks, Maryland (BD Diagnostics).

Acquisition Integration: CareFusion & C.R. Bard in the Registries

BD's growth over the past decade has been heavily shaped by two mega-acquisitions: CareFusion in 2015 (valued at USD 12.2 billion) and C.R. Bard in 2017 (valued at USD 24 billion).

Examining global registration databases provides empirical evidence of how these acquisitions are integrated. Instead of a rapid consolidation into a single "BD" entity, databases show that legacy manufacturing names, corporate entities, and brand names remain active for years post-transaction.

Legacy Entity Persistence

In many international registries, registrations are tied to the legal manufacturer entity listed on the physical device label. Because updating labels globally is a massive regulatory undertaking (requiring updates to technical files, new notifications to ministries of health, and packaging audits), BD continues to register products under legacy corporate names:

Canada MDALL: Of the 659 active registrations under the BD combined query, 426 are held under legacy subsidiary names, including C.R. Bard (164), Bard Peripheral Vascular (97), and CareFusion (22), compared to 326 under Becton, Dickinson and Company.
Saudi Arabia SFDA: Out of 3,327 active records, legacy CareFusion entities account for 1,173 entries, and Bard-related entities (Bard Peripheral, C.R. Bard, Angiomed) account for 369 entries. Becton Dickinson & Co accounts for 540 entries.
Australia ARTG: Legacy names account for 212 of the 433 listings, with CareFusion representing 141 and Bard/Davol representing 71.

Operational Implication for Market Access

For regulatory affairs teams, this persistence means that when performing due diligence on a competitor's portfolio or seeking to transition a portfolio, one must search under all legacy names. A query restricted only to "Becton Dickinson" will miss more than half of the company's active product registrations in key markets.

Importer vs. Product Registration: Channel Footprint

In addition to product registries, mapping BD's local importer and distributor networks provides insight into its regional commercial strategies.

Direct Subsidiary vs. Third-Party Distributor

The data shows a clear pattern: in major, high-volume markets, BD operates via its own direct local subsidiaries, which act as the authorized importer or local representative of record. In smaller or more restricted markets, BD relies on third-party local distributors:

Colombia (INVIMA): BD operates via Becton Dickinson de Colombia Ltda, which is listed as the registrant (Titular) for 3,356 of the 5,000 active records. The company also holds a certified importer license (Certificado de Importador, CCAA) issued in September 2024.
South Korea (MFDS): BD operates through 벡톤디킨슨코리아(주) (BD Korea Co., Ltd.), which is listed as a licensed importer in Seoul.
Canada (Health Canada MDEL): BD operates through Becton Dickinson Canada Inc., holding an active Medical Device Establishment License (MDEL #204) in Mississauga, Ontario, which permits direct importation and distribution.
Singapore (HSA): HSA registries list Becton Dickinson Holdings Pte Ltd as the registrant for 344 active registrations, indicating a centralized direct regional hub.

This direct subsidiary model allows BD to maintain tight control over its local supply chain, manage price structures, and coordinate directly with ministries of health. In contrast, in markets like Kazakhstan or Ecuador, registrations are often held by local third-party distributors or are registered at the product-brand level only, meaning BD must coordinate its regulatory strategy through external intermediaries.

Sourcing and Supply Chain Integration

BD's manufacturing network is highly globalized, which introduces unique regulatory and logistical dependencies. By analyzing the country of origin listed in global registries, we can map BD's manufacturing hubs:

High-Volume Consumables (Fraga, Spain & Plymouth, UK): The ANVISA and UAE EDE databases show that a massive portion of BD's syringes, needles, and pre-analytical tubes are manufactured in Fraga, Spain. This facility is one of Europe's largest medical manufacturing plants.
Infusion and Diagnostic Hardware (Canaan, USA & Sandy, USA): Registration details from the CDSCO and TGA reveal that BD's infusion pumps (Alaris line) and diagnostic instruments (BD MAX, BD BACTEC) are primarily manufactured in the United States.
Vascular and Surgical Implants (Tempe, USA & Germany): The legacy C.R. Bard portfolios are concentrated in Tempe, Arizona (Bard Peripheral Vascular) and Karlsruhe, Germany (Angiomed GmbH), indicating specialized manufacturing clusters.

For supply chain managers, this distribution highlights the risk of tariff exposure. Products imported into the US from BD’s European facilities (such as Fraga or Plymouth) or from Mexican assembly sites face different tariff schedules compared to domestic US production.

FAQs

How many medical device registrations does BD have globally?

In the United States alone, BD holds over 10,700 active UDI listings, 1,900+ 510(k) clearances, and 300+ PMA approvals. Internationally, its registrations range from hundreds to thousands of records per market, such as 659 in Canada, 433 in Australia, 1,734 in India, and 5,000 in Colombia.

Are BD's CareFusion and C.R. Bard products still registered under their legacy names?

Yes. Due to the high regulatory cost of updating global manufacturing labels, a large portion of BD's active registrations remain under legacy entity names, such as "C.R. Bard, Inc.", "Bard Peripheral Vascular", or "CareFusion Switzerland Sàrl". In Canada, legacy names represent over 60% of BD's combined active registrations.

Does BD sell directly or through distributors in international markets?

BD utilizes a hybrid model. In major markets like Canada, Colombia, South Korea, and Singapore, BD operates via direct local subsidiaries (e.g., BD Canada, BD Colombia, BD Korea) that hold establishment licenses. In smaller or developing markets, BD partners with independent local distributors who manage local customs clearances.

What is the difference between product registration and importer establishment listings for BD?

Product registration (such as Canada MDALL or India CDSCO listings) authorizes a specific medical device to be sold in the market. Importer establishment listings (such as Canada MDEL or Colombia CCAA) license the physical business entity to import and distribute devices. A company must have both elements in place to legally commercialize a product.

Internal Links and Context

For more information on large-scale medical technology mergers, see our guide on the Waters and BD Biosciences merger to understand its impact on life sciences and diagnostics.
For information on general market access frameworks, see the USA medical device registration US agent pricing guide.
For general supply chain strategies, consult our comprehensive Medical device supply-chain risk management guide.