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 comparableCNChinaNMPA
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.
Australia, Hong Kong, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
How these numbers were verified
record-verifiedCompany-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.
Same-named companies — This database also contains companies with near-identical names: Medrad, Inc. / Bayer Medical Care, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.
Company information
- Country
- USA
- City
- Indianola
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
FDA 510(k) clearances by year
12013 · K131517
12014 · K132928
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 |
Signed in · open all 30 sampled records for this company and export → · Export rows left this month —/100