HomeMalaysiaMed-Care Sdn. Bhd.

Med-Care Sdn. Bhd.

Malaysia · Darul Ehsan
✓ 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
3510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
17registered devices
Class I 4Class II 13
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
0active device licences
5 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 States0 registration records, 3 510(k), 0 PMA, 342 excluded
Brazil17 confirmed, 130 excluded
Saudi Arabia0 confirmed, 34 excluded
Canada0 confirmed, 48 excluded
Manufacturer names merged into this page: MED-U-CARE HEALTH, INC. · BIO MED HEALTH CARE PRODUCTS PVT.LTD (PALWAL) · BIO-MED HEALTH CARE PRODUCTS PVT. LTD. · BIO MED HEALTH CARE PRODUCTS PVT.LTD.
Same-named companies — This database also contains companies with near-identical names: MED-U-CARE HEALTH, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia
City
Darul Ehsan

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

11990 · K891490
12003 · K032656
12004 · K040251

Registration details (sample)

MarketIdentifierNameClass / date
USK040251GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 24045872004-02-20
USK032656GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X2003-10-30
USK891490SEAMLESS LATEX PATIENT EXAMINATION GLOVES1990-01-23
BR82942919017CATETER INTRAVENOSO COM DISPOSITIVO DE SEGURANÇA TERAClass II
BR82942919015TORNEIRA 3 VIAS TERAClass II
BR82942919019CATETER INTRAVENOSO TERAClass II

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