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Bayer Medical Care B.V.

Netherlands · Maastricht Limburg

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 2Class II 14Class III 0

plus 82 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 1Class II 16

22 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

17active device licences

Class II 11Class III 5Class IV 1

33 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States82 registration records, 12 510(k), 0 PMA, 11 excluded

Brazil17 confirmed, 1 excluded

Canada17 confirmed, 5 excluded

Manufacturer names merged into this page: Bayer Medical Care Inc. · Bayer Medical SRL · Bayer Medical Care B.V. · BAYER MEDICAL CARE INC. ALSO DOING BUSINESS AS MEDRAD, INC. · BAYER MEDICAL CARE INCORPORATED · BAYER MEDICAL CARE INC.

FDA 510(k) clearances by year

12013

12014

12015

32018

22019

12020

12025

22026

FDA listed device types

showing 8 of 16

Cephalometer 1System, Nuclear Magnetic Resonance Imaging 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Pump, Infusion 1Set, I.V. Fluid Transfer 1Iodinated Contrast Media Transfer Tubing Set 1Set, Administration, Intravascular 1Injector And Syringe, Angiographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253688	MEDRAD® Imaging Bulk Package Transfer Spike	2026-06-12
US	K252891	MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)	2026-02-13
US	K250893	Ball Joint Guide Array (66295)	2025-09-04
BR	80384389008	Tubo Descartável do Paciente Medrad MRXperion	Class II
BR	80384389009	Kit Multi-Paciente Medrad MRXperion	Class II
BR	80384380067	MRXperion Seringa XP65/115VS	Class II
CA	11	MEDRAD VISTRON CT INJECTION SYSTEM	Class II
CA	1421	MEDRAD PULSAR ULTRASOUND INJECTION SYSTEM	Class II
CA	7196	MCT PLUS FRONTLOAD CT INJECTION SYSTE	Class II

Bayer Medical Care B.V.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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