HomeChinaChangzhou Geasure Medical Apparatus And Instruments Co., Ltd.

Changzhou Geasure Medical Apparatus And Instruments Co., Ltd.

China · 常州
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000043758Unified social credit code 91320412MA1M9KY84E

This company holds 100 NMPA certificates in China and has registrations in European Union, United States — 2 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
100China registrations
Class I 50Class II 7Class III 43
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class IIb 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
25listed device types
Class I 20Class II 5Class III 0
plus 24 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union1,992 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States24 registration records, 4 510(k), 0 PMA
China100 certificates (Class III 43 / II 7 / I 50), as of 2026-09-04
Manufacturer names merged into this page: CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000043758
EU authorised representative
MedPath GmbH
Unified social credit code
91320412MA1M9KY84E
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
184

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
2015-10-15
Registered capital
CNY 170,885,000
Paid-in capital
CNY 170,885,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-08-15
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle 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

12022 · K222031
32023 · K232394

FDA listed device types

showing 8 of 25
Template 1Rasp 1Pusher, Socket 1Impactor 1Screwdriver 1Reamer 1Starter, Bone Screw 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263130518门型钉Class III
CN国械注准20263130461不可吸收带线锚钉Class III
CN国械注准20263130052聚醚醚酮带线锚钉Class III
CN国械注准20253132503聚醚醚酮带线锚钉Class III
EU06931712400892Intramedullary Nail SystemClass IIb
EU06931712405774Intramedullary Nail SystemClass IIb
EU06970356712602Intramedullary Nail SystemClass IIb
EU06970356712589Intramedullary Nail SystemClass IIb
USK232394Internal Locking Plate and Screw Fixation System2023-12-15
USK230456SGM Femoral Nail System2023-06-30
USK223776PEEK Spinal Infusion Cage2023-03-03

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