HomeChinaYonye Medical Instrument (Changzhou) Co., LTD.

Yonye Medical Instrument (Changzhou) Co., LTD.

China · 常州 · www.cnyonye.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000044824Unified social credit code 91320412MABLXW3B29

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, Brazil, Taiwan, Australia, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class I 4
as of 2026-09-04
EUEuropean UnionEUDAMED
9UDI-DI device records
Class I 9
USUnited StatesFDA openFDA
3listed device types
Class I 3Class II 0Class III 0
plus 3 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
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
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union9 raw hits, 0 excluded, 9 confirmed
United States3 registration records, 0 510(k), 0 PMA
China4 certificates (Class III 0 / II 0 / I 4), as of 2026-09-04
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: YONYE MEDICAL INSTRUMENT (CHANGZHOU) CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000044824
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91320412MABLXW3B29
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
9
Annual revenue
under RMB 5M
Website
www.cnyonye.com

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
2022-04-22
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-10-14
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 listed device types

Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Bandage, Elastic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏常械备20230203创口贴Class I
CN苏常械备20230161弹性绷带Class I
CN苏常械备20220396医用橡皮膏Class I
CN苏常械备20220395医用胶带Class I
EU06975597900115Class I
EU06975597900160Class I
EU06975597900337Class I
EU06975597900313Class I
BR81510140003BANDAGEM KINESIO TAPEClass I

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