Home›USA›BAYER MEDICAL CARE INC. ALSO DOING BUSINESS AS MEDRAD, INC.

BAYER MEDICAL CARE INC. ALSO DOING BUSINESS AS MEDRAD, INC.

USA · Indianola

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

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

19valid device licences

Class II 19

SGSingaporeHSA SMDR

9device registrations

CLASS B 2CLASS C 7

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

17active ARTG entries

Class I 5IIa 6IIb 5Class Is (sterile) 1

HKHong KongMDACS

5valid listings

Class III 5

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

23active registrations

Class 2a 15Class 2b 8

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 States0 registration records, 2 510(k), 0 PMA, 3 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: BAYER MEDICAL CARE INC. ALSO DOING BUSINESS AS MEDRAD, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K132928	MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE	2014-01-23
US	K131517	MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING	2013-08-02
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 INC. ALSO DOING BUSINESS AS MEDRAD, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies