HomeChinaJiangsu Changmei Medtech Co., Ltd.

Jiangsu Changmei Medtech Co., Ltd.

China · 北京 · www.czmed.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000012609Unified social credit code 91320412072779017U

This company holds 33 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
33China registrations
Class I 1Class II 29Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
63UDI-DI device records
Class I 4Class IIa 59
USUnited StatesFDA openFDA
8listed device types
Class I 6Class II 2Class III 0
plus 8 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 1Class IIa 4
BRBrazilANVISA
7registered devices
Class I 5Class II 2
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
8valid device licences
Class I 2Class II 6
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 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 Union63 raw hits, 0 excluded, 63 confirmed
United States8 registration records, 1 510(k), 0 PMA
China33 certificates (Class III 3 / II 29 / I 1), as of 2026-09-04
United Kingdom5 confirmed, 0 excluded
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: JIANGSU CHANGMEI MEDTECH CO.,LTD · JIANGSU CHANGMEI MEDTECH CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000012609
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Wellkang Ltd
Unified social credit code
91320412072779017U
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
197
Annual revenue
RMB 100–500M
Website
www.czmed.com
Product categories
手术器械

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
2013-07-17
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-09-02
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseSRDI SME

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

12023 · K223709

FDA listed device types

Forceps, Biopsy, Non-Electric 1Spinal Channeling Instrument, Vertebroplasty 1Tamp 1Dispenser, Cement 1Injector, Vertebroplasty (Does Not Contain Cement) 1Orthopedic Manual Surgical Instrument 1Arthroscope 1Dilator, Esophageal 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263010932一次性使用乳头括约肌切开刀Class III
CN国械注准20243140156一次性内镜用注射针Class III
CN国械注准20173010741一次性使用电圈套器Class III
CN苏械注准20262021218一次性使用圈套器Class II
EU06923558506203Class IIa
EU06923558505961Class IIa
EU06923558505626Class IIa
EU06923558504933Class IIa
UK58031Kyphoplasty Tool KitClass IIa
UK17541Balloon InflatorClass I
UK62109Bougie Dilator SetsClass IIa
USK223709Kyphoplasty Balloon Catheter2023-08-16
BR82523860019Escova Citológica EndoscópicaClass II
BR82523860028Escova de CitologiaClass I
BR82523860012Pinça Hose TypeClass I

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