HomeChinaShanghai Kinetic Medical Co., Ltd.

Shanghai Kinetic Medical Co., Ltd.

China · Shanghai · www.kineticmedinc.com.cn
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000017688

This company has registrations in European Union, United States, Brazil, Singapore, Australia, Israel, Russia — 7 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
55UDI-DI device records
Class I 8Class IIa 47
USUnited StatesFDA openFDA
19listed device types
Class I 17Class II 2Class III 0
plus 18 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
3registered devices
Class II 3
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
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
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 Union62 raw hits, 7 excluded, 55 confirmed
United States18 registration records, 1 510(k), 0 PMA, 15 excluded
United Kingdom0 confirmed, 2 excluded
Brazil3 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SHANGHAI KiNETIC MEDICAL CO LTD · SHANGHAI KINETIC MEDICAL CO., LTD · SHANGHAI KINETIC CO. LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000017688
EU authorised representative
Prolinx GmbH

Company information

Country
China
City
Shanghai
Website
www.kineticmedinc.com.cn
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsX-ray (analog, digital, mobile)

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

12012 · K113742

FDA listed device types

showing 8 of 19
Arthroscope 1Cement, Bone, Vertebroplasty 1Dilator, Catheter 1Device, Percutaneous, Biopsy 1Rongeur 1Cannula, Surgical, General & Plastic Surgery 1Probe 1Chisel, Surgical, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06938695501066Class I
EU06938695542007Locking SyringeClass I
EU06938695520012Kyphoplasty Tool KitClass IIa
EU06938695520029Kyphoplasty Tool KitClass IIa
USK113742KMC KYPHOPLASTY SYSTEM2012-09-17
BR80102511810DISPOSITIVO PARA CIFOPLASTIA KMCClass II
BR10378649009DISPOSITIVO PARA VERTEBROPLASTIA KMCClass II
BR80299570010KIT INSTRUMENTAL PARA CIFOPLASTIA KMCClass II

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