HomeChinaTUGE Healthcare

TUGE Healthcare

China · 南京 · www.tugemedical.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000018925Unified social credit code 91320115MA1W3RBK1F

This company holds 11 NMPA certificates in China and has registrations in European Union, Brazil — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
11China registrations
Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
172UDI-DI device records
Class I 108Class IIa 64
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
4registered devices
Class I 1Class II 3
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 Union172 raw hits, 0 excluded, 172 confirmed
China11 certificates (Class III 0 / II 11 / I 0), as of 2026-09-04
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: NANJING TUGE HEALTHCARE CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000018925
EU authorised representative
MedPath GmbH
Unified social credit code
91320115MA1W3RBK1F
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
79
Annual revenue
under RMB 5M
Website
www.tugemedical.com
Product categories
医用成像器械

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
2018-02-08
Registered capital
CNY 4,593,780
Paid-in capital
CNY 3,865,176
Legal form
Limited liability company
Industry classification
Wholesale trade
Last approval date
2026-04-10
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseSRDI SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20262060799三维电子胸腹腔镜Class II
CN苏械注准20252060797医用气腹机Class II
CN苏械注准20242062195医用内窥镜冷光源Class II
CN苏械注准20242062177超高清内窥镜摄像系统Class II
EU069744396717323D Video EndoscopeClass IIa
EU069744396717253D Video EndoscopeClass IIa
EU069744396717183D Video EndoscopeClass IIa
EU069744396717013D Video EndoscopeClass IIa
BR80493669012Endoscópio de vídeo 3DClass II
BR80493669013Unidade de controle da câmera 3DClass II
BR80493669014InsufladorClass II

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