HomeNetherlandsCARDIO MEDICAL GmbH

CARDIO MEDICAL GmbH

Netherlands · Amsterdam
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia — 5 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
2listed device types
Class I 1Class II 1Class III 0
plus 4 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
70registered devices
Class I 1Class II 69
76 including historic records
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
22active ARTG entries
Class I 22
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 States4 registration records, 9 510(k), 0 PMA, 46 excluded
Brazil70 confirmed, 2 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: CARDIO MEDICAL PRODUCTS, INC. · CARDIO MEDICAL INDUSTRIAL LTDA · CARDIO MEDICAL GmbH
Same-named companies — This database also contains companies with near-identical names: CARDIO MEDICAL PRODUCTS, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Amsterdam

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

11985
11986
11987
11998
32011
12019
12024

FDA listed device types

Dc-Defibrillator, Low-Energy, (Including Paddles) 1Barrier, Control Panel, X-Ray, Movable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232721Lifetech Cardio Temporary Pacemaker2024-01-07
USK182839Lifetech Cardio Model 8301 Temporary Pacemaker2019-02-28
USK103651CARDIOMED2011-10-04
BR81466619064Aquecedor de Fluídos para Cateter UretralClass II
BR81466619061HEMOCONCENTRADOR PARA CECClass II
BR81466619063Conjunto de Tubos TK Especial para CEC Adulto FAEClass II
SAME0000001124SFDAA00003CV MICS Knot Pusher
SAME0000001123SFDAA00003CV MICS Valve Rongeur

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