HomeChinaXinkang Medical Co Ltd

Xinkang Medical Co Ltd

China · Taizhou · www.xinkand.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-PR-000050271Unified social credit code 91440300MA5FBYB96F

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia, Australia, Israel, Russia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
169UDI-DI device records
Class I 121Class IIb 20IVD A 28
USUnited StatesFDA openFDA
35listed device types
Class I 30Class II 3Class III 0unclassified 2
plus 38 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
5registered devices
Class I 5
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered 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
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
Class I 8IVD Class 1 1Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union169 raw hits, 0 excluded, 169 confirmed
United States38 registration records, 2 510(k), 0 PMA
China4 certificates (Class III 0 / II 4 / I 0), as of 2026-09-04
Brazil5 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD · XINKANG MEDICAL INSTRUMENT CO. LTD. · JIANGSU XINKANG MEDICAL INSTRUMENTS CO., LTD · Taizhou Xinkang Medical Materials Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-PR-000050271
EU authorised representative
MedPath GmbH
Unified social credit code
91440300MA5FBYB96F
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Taizhou
Social-insurance enrolees
15
Annual revenue
RMB 100–500M
Website
www.xinkand.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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.

Business registration

Registration status
Active
Incorporated
2018-10-18
Registered capital
CNY 5,000,000
Paid-in capital
CNY 1,875,850
Legal form
Limited liability company
Industry classification
Wholesale trade
Last approval date
2025-11-24
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

22020 · K201359

FDA listed device types

showing 8 of 35
Pad, Eye 1Forceps 1Mouthpiece, Breathing 1Mask, Oxygen, Non-Rebreathing 1First Aid Kit Without Drug 1Bedding, Disposable, Medical 1Dressing, Wound, Occlusive 1Solution, Isotonic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252071164重复性心电电极Class II
CN粤械注准20252071112体温传感器Class II
CN粤械注准20232070883一次性脉搏血氧饱和度传感器Class II
CN粤械注准20232070882脉博血氧饱和度传感器Class II
EU08719179229441First Aid KitClass I
EU08719179229434First Aid KitClass I
EU06953102652858First Aid KitClass I
EU06953102624817Sterile GauzeClass I
USK201359ECG Cables and Leadwires2020-10-01
USK201360Reusable and Disposable SpO2 Sensors2020-08-19
BR81313770055FAMÍLIA DE CENTRÍFUGAS LABORATORIAIS SPIN MAX TD4 / TD5Class I
BR81313770056FAMÍLIA DE MINI CENTRÍFUGAS LABORATORIAIS SPIN MAXClass I
BR81313770057CENTRÍFUGA LABRATORIAL SPIN MAX 800Class I
SAME0000008274SFDAA00001GAUZE SPONGES
SAME0000022431SFDAA00001Cloth Cleaning

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