HomeChinaHUGER MEDICAL INSTRUMENT CO., LTD

HUGER MEDICAL INSTRUMENT CO., LTD

China · Shanghai · www.huger.cn
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000001128Unified social credit code 91310000733382384X

This company holds 26 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Russia — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
26China registrations
Class II 26
as of 2026-09-04
EUEuropean UnionEUDAMED
30UDI-DI device records
Class I 1Class IIa 29
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 2Class IIa 2
BRBrazilANVISA
9registered devices
Class II 9
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
5active ARTG entries
Class I 1IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 Union30 raw hits, 0 excluded, 30 confirmed
United States0 registration records, 2 510(k), 0 PMA
China26 certificates (Class III 0 / II 26 / I 0), as of 2026-09-04
United Kingdom4 confirmed, 0 excluded
Brazil9 confirmed, 0 excluded
Manufacturer names merged into this page: HUGER MEDICAL INSTRUMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000001128
EU authorised representative
Lotus NL B.V.
UK responsible person
BioSpectrum Ltd
Unified social credit code
91310000733382384X
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
65
Annual revenue
RMB 30–50M
Website
www.huger.cn
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
2001-11-22
Registered capital
CNY 10,667,000
Paid-in capital
CNY 10,667,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2022-08-04
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative 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

12023 · K230475
12024 · K241639

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20262060215纤维鼻咽喉镜Class II
CN沪械注准20252060438内窥镜冷光源Class II
CN沪械注准20252060155电子内窥镜图像处理器Class II
CN沪械注准20252060152内窥镜冷光源Class II
EU06953393180016Class I
EU06953393105156Class IIa
EU06953393165235Class IIa
EU06953393165228Class IIa
UK18034Medical Video ProcessorClass I
UK34540HUGER Image ProcessorClass I
UK61728Single Use CystoscopeClass IIa
USK241639Single-use Video Ureterorenoscope (SVU-220US)2024-07-01
USK230475Medical Video Endoscope System2023-11-03
BR80047309254Broncoscópio de Vídeo de Uso ÚnicoClass II
BR80047309255Cistoscópio de Vídeo de Uso ÚnicoClass II
BR80047309256Processador de Vídeo MédicoClass II

Similar companies

ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Anhui Tiankang Medical Technology Co., Ltd
China · markets 10
Auckland Medical Polymer (Tianjin) Co., Ltd.
China · markets 9
Baisheng Medical Co., Ltd.
China · markets 9
Beijing Datsing Bio-Tech Co., Ltd.
China · markets 2
Beijing Eternity Electronic Technology Co.,Ltd
China · markets 2
Is this your company? Claim the page, add information or report a data error.Claim / report an error →