HomeChinaGemtier Medical (Shanghai) Inc.

Gemtier Medical (Shanghai) Inc.

China · Shanghai · www.gemtier.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000003835Unified social credit code 91310116134206848C

This company holds 38 NMPA certificates in China and has registrations in European Union, United States, Brazil, Canada — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
38China registrations
Class II 4Class III 34
as of 2026-09-04
EUEuropean UnionEUDAMED
47UDI-DI device records
Class I 8Class IIa 39
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 4Class III 0
plus 2 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
7registered devices
Class II 7
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
1 including historic records
TWTaiwanTFDA
0valid device licences
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 Union47 raw hits, 0 excluded, 47 confirmed
United States2 registration records, 5 510(k), 0 PMA
China38 certificates (Class III 34 / II 4 / I 0), as of 2026-09-04
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: Gemtier Medical (Shanghai) Inc. · GEMTIER MEDICAL (SHANGHAI) INC.

Regulatory identity

EU manufacturer SRN
CN-MF-000003835
EU authorised representative
CMC Medical Devices & Drugs SL
Unified social credit code
91310116134206848C
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shanghai
Social-insurance enrolees
312
Annual revenue
RMB 100–500M
Website
www.gemtier.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
1988-01-26
Registered capital
CNY 40,200,000
Paid-in capital
CNY 40,200,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-07-29
Recognitions
National High-Tech EnterpriseRecognised enterprise technology centre

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

12017 · K170276
12020 · K192679
22021 · K202493
12022 · K212652

FDA listed device types

Syringe, Antistick 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263140073一次性使用精密过滤输液器 带针Class III
CN国械注准20243140651一次性使用输液器Class III
CN国械注准20243140274一次性使用避光输液延长管Class III
CN国械注准20233141941一次性使用泵用精密过滤输液器Class III
EU16955356125031EVA Container Class I
EU16955356113403Empty EVA Container with Gravity Transfer Set, 3000ml Class I
EU16955356113458Infusion Set for Single Use, Auto-fill (De-bubble) + Auto-Stop precision filter + Auto-Prime cap with Injection site Protector, PVC tubingClass I
EU16955356113441Infusion Set for Single Use, Auto-Stop Valve + Auto-Prime cap with Injection site Protector, PVC tubingClass I
USK212652Sterile Syringe with Fixed Safety Needle for Single Use2022-03-02
USK202493Medical Face Mask2021-02-04
USK202331Medical Face Mask2021-02-02
BR81718449001Equipo de Uso Único de Infusão GravitacionalClass II
BR80943579001Bolsa EVA para nutrição parenteralClass II
BR10301169009Conjunto de Coleta de Sangue de Segurança/Conjunto de Infusão para UsoClass II

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