HomeChinaGentec (Shanghai) Corporation

Gentec (Shanghai) Corporation

China · 上海 · www.gentec.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000012841Unified social credit code 913100006072645397

This company holds 23 NMPA certificates in China and has registrations in European Union, United States, Brazil, Canada, Taiwan, Australia, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
23China registrations
Class I 8Class II 15
as of 2026-09-04
EUEuropean UnionEUDAMED
67UDI-DI device records
Class IIa 67
USUnited StatesFDA openFDA
12listed device types
Class I 9Class II 3Class III 0
plus 12 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
4registered devices
Class I 3Class II 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
5 including historic records
TWTaiwanTFDA
10valid device licences
Class I 10
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IIa 3IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
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 Union97 raw hits, 30 excluded, 67 confirmed
United States12 registration records, 1 510(k), 0 PMA
China23 certificates (Class III 0 / II 15 / I 8), as of 2026-09-04
United Kingdom0 confirmed, 2 excluded
Brazil4 confirmed, 1 excluded
Manufacturer names merged into this page: GENTEC (SHANGHAI) CORPORATION · GENTEC (SHANGAI) CORPORATION

Regulatory identity

EU manufacturer SRN
CN-MF-000012841
EU authorised representative
MedNet EC-REP C IIb GmbH
Unified social credit code
913100006072645397
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
451
Annual revenue
RMB 100–500M
Website
www.gentec.com
Product categories
医院建设及后勤

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
1993-10-06
Registered capital
USD 7,490,000
Paid-in capital
USD 7,490,000
Legal form
Limited liability company (foreign-invested, not wholly owned)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-06-06
Recognitions
National High-Tech EnterpriseSRDI SMEInnovative 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

12015 · K142291

FDA listed device types

showing 8 of 12
Flowmeter, Tube, Thorpe, Back-Pressure Compensated 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Accessory, Surgical Apparel 1Regulator, Pressure, Gas Cylinder 1Cannula, Nasal, Oxygen 1Gauge, Gas Pressure, Cylinder/Pipeline 1Tubing, Pressure And Accessories 1Yoke Assembly, Medical Gas 1

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20242080238一次性呼吸管路组Class II
CN沪械注准20232080020医用气体报警系统Class II
CN沪械注准20222080217医用气体汇流排Class II
CN沪械注准20222080167鼻塞导管Class II
EU06970966665374Low-Pressure Hose Assemblies for use with Medical GasesClass IIa
EU06970966665367Low-Pressure Hose Assemblies for use with Medical GasesClass IIa
EU06970966665350Low-Pressure Hose Assemblies for use with Medical GasesClass IIa
EU06970966665343Low-Pressure Hose Assemblies for use with Medical GasesClass IIa
USK142291GMX Series Medical Air/Oxygen Blender2015-05-19
BR10345339003Reguladores para Gases Medicinais Série 197MClass II
BR80239100005Regulador de sucção da série 882VRClass I
BR80626510007PAINEL DE ALARME GUMACSClass I

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