HomeChinaCanwell Medical Co., Ltd.

Canwell Medical Co., Ltd.

China · Jinhua Zhejiang · www.canwellmed.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000025329Unified social credit code 91330700768670546E

This company holds 135 NMPA certificates in China and has registrations in European Union, United States, Brazil, Taiwan, Australia, Russia — 6 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
135China registrations
Class I 47Class II 21Class III 67
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
42listed device types
Class I 15Class II 27Class III 0
plus 27 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
8registered devices
Class I 6Class II 2
12 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
IIa 3IIb 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
5active registrations
Class 1 1Class 2b 3Class 3 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 Union2,273 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States27 registration records, 3 510(k), 0 PMA
China135 certificates (Class III 67 / II 21 / I 47), as of 2026-09-04
Brazil8 confirmed, 0 excluded
Manufacturer names merged into this page: CANWELL MEDICAL CO., LTD. · CANWELL MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000025329
EU authorised representative
Llins Service & Consulting GmbH
Unified social credit code
91330700768670546E
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Jinhua Zhejiang
Social-insurance enrolees
477
Annual revenue
under RMB 5M
Website
www.canwellmed.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationImplants & prosthetics

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
2004-11-03
Registered capital
CNY 60,300,000
Paid-in capital
CNY 60,300,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Other manufacturing
Last approval date
2025-03-17
Recognitions
National High-Tech EnterpriseRecognised enterprise technology centreAbove-designated-size industrial 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

12015 · K142943
12016 · K161151
12025 · K242973

FDA listed device types

showing 8 of 42
Template 1Reamer 1Chisel, Surgical, Manual 1Bit, Drill 1Gauge, Depth 1Driver, Prosthesis 1Extractor 1Clamp 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263171358复合基台Class III
CN国械注准20263131014单髁膝关节系统Class III
CN国械注准20263130485可吸收带线锚钉Class III
CN国械注准20263100048富血小板血浆制备器Class III
EU06932249265237CANWELLClass I
EU06942980291938CANWELLClass I
EU06942980291617CANWELLClass I
EU06932249264230CANWELLClass I
USK242973CanMINI Hand and Foot System2025-04-24
USK161151Spinal fixation system2016-09-21
USK142943Metallic Locking Bone Plate and Screw2015-08-03
BR83082930002Kit Instrumental Endoscopia Biportal Unilateral UBEClass I
BR83082939003Lâmina de ShaverClass II
BR83082930003KIT INSTRUMENTAL MEDICINA ESPORTIVA LCA/LCPClass I

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