HomeChinaCareMax Co. Ltd.

CareMax Co. Ltd.

China · Suzhou · www.caremax.com.cn
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000014064

This company has registrations in European Union, United States, United Kingdom, Taiwan — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
148UDI-DI device records
Class I 148
USUnited StatesFDA openFDA
17listed device types
Class I 14Class II 1Class III 0unclassified 2
plus 18 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class I 7
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
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
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.

European Union211 raw hits, 63 excluded, 148 confirmed
United States18 registration records, 0 510(k), 0 PMA, 2 excluded
United Kingdom7 confirmed, 1 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia0 confirmed, 3 excluded
Manufacturer names merged into this page: CAREMAX CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000014064
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
SUNGO Certification Company Limited

Company information

Country
China
City
Suzhou
Website
www.caremax.com.cn
Product categories
Healthcare Systems, Education & Global HealthHealthcare services & ecosystem

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 listed device types

showing 8 of 17
Mask, Surgical 1Forceps 1Gauze / Sponge,Nonresorbable For External Use 1Scissors, Medical, Disposable 1Tourniquet Kit 1Mask, Oxygen, Non-Rebreathing 1Sling, Arm 1First Aid Kit Without Drug 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06974523991579Sport TapeClass I
EU06974523991562Sport TapeClass I
EU06974523991555Cohesive Elastic Bandage, for fixingClass I
EU06974523991548Cohesive Elastic Bandage, for fixingClass I
UK47011Sterile Dressing PacksClass I
UK47011Dressing PacksClass I
UK48131Sterile Wound CompressesClass I

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