HomeChinaBaoying County Fukang Medical Appliance Co.,Ltd

Baoying County Fukang Medical Appliance Co.,Ltd

China · 扬州 · www.china-fk.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000010780Unified social credit code 913210236709684756

This company holds 9 NMPA certificates in China and has registrations in European Union, Brazil, Saudi Arabia, Russia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class I 5Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
21UDI-DI device records
Class I 14Class IIa 7
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
6registered 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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 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 Union21 raw hits, 0 excluded, 21 confirmed
China9 certificates (Class III 0 / II 4 / I 5), as of 2026-09-04
Brazil1 confirmed, 0 excluded
Saudi Arabia6 confirmed, 0 excluded
Manufacturer names merged into this page: BAOYING COUNTY FUKANG MEDICAL APPLIANCE CO., LTD. · Baoying County Fukang Medical Appliance Co Ltd · BAOYING COUNTY FUKANG MEDICAL APPLIANCE CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000010780
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
913210236709684756
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
20
Annual revenue
RMB 30–50M
Website
www.china-fk.com
Product categories
医用耗材注输、护理和防护器械

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
2008-01-03
Registered capital
CNY 10,000,000
Paid-in capital
CNY 1,700,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-09-11
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.

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20182140966一次性使用酒精消毒片Class II
CN苏械注准20182140963一次性使用酒精消毒棉签Class II
CN苏械注准20182140962一次性使用碘伏消毒棉签Class II
CN苏械注准20182140961一次性使用碘伏消毒片Class II
EU06951933490106Lemon glycerin swabstickClass I
EU06951933490540Lemon glycerin swabstickClass I
EU06951933490700Lemon glycerin swabstickClass I
EU06951933490441Lemon glycerin swabstickClass I
BR10379860137ESPÁTULA DE AYREClass I
SAME0000009107SFDAA00001CHAINMED
SAME0000009107SFDAA00002CHAINMED

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