HomeChinaOrtus Medi-tech Co., Ltd.

Ortus Medi-tech Co., Ltd.

China · Shenzhen · www.ortusmed.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000031033

This company has registrations in European Union, United States, Brazil, South Korea — 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
168UDI-DI device records
Class I 93Class IIa 75
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
12registered devices
Class I 2Class II 10
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 Union168 raw hits, 0 excluded, 168 confirmed
United States2 registration records, 0 510(k), 0 PMA
United Kingdom0 confirmed, 2 excluded
Brazil12 confirmed, 1 excluded
Manufacturer names merged into this page: ORTUS MEDI-TECH CO., LTD. · ORTUS MEDI-TECH CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000031033
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)

Company information

Country
China
City
Shenzhen
Website
www.ortusmed.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentCardiology & vascular medicine

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

Tourniquet, Pneumatic 1Syringe, Balloon Inflation, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06972985352372Disposable Inflation DeviceClass I
EU06972985350286Disposable Inflation DeviceClass I
EU06972985352365Disposable Guide WireClass IIa
EU06972985352358Disposable Guide WireClass IIa
BR81506640023BANDAGEM DE COMPRESSÃO FEMORAL DESCARTÁVEL ORTUSClass I
BR10210419011CONECTOR EM YClass II
BR10210419012MANIFOLDClass II

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