HomeChinaBEIJING FANXING GUANGDIAN MEDICAL TREATMENT EQUIPMENT CO.,LTD

BEIJING FANXING GUANGDIAN MEDICAL TREATMENT EQUIPMENT CO.,LTD

China · 北京 · www.bjfxgd.com.cn
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000026984Unified social credit code 91110108634343996M

This company holds 32 NMPA certificates in China and has registrations in European Union, United States, Russia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
32China registrations
Class I 10Class II 22
as of 2026-09-04
EUEuropean UnionEUDAMED
2UDI-DI device records
Class I 2
USUnited StatesFDA openFDA
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 0 510(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
4active registrations
Class 1 1Class 2a 3
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 Union4 raw hits, 2 excluded, 2 confirmed
United States5 registration records, 0 510(k), 0 PMA
China32 certificates (Class III 0 / II 22 / I 10), as of 2026-09-04
Manufacturer names merged into this page: BEIJING FANXING GUANGDIAN MEDICAL TREATMENT EQUIPMENT CO LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000026984
EU authorised representative
Sungo Cert GmbH
Unified social credit code
91110108634343996M
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
50
Annual revenue
RMB 50–100M
Website
www.bjfxgd.com.cn
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
1998-03-06
Registered capital
CNY 30,000,000
Paid-in capital
CNY 30,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-03-06
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle enterpriseAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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 listed device types

Forceps, General & Plastic Surgery 1Source, Carrier, Fiberoptic Light 1Scissors, General, Surgical 1Accessories, Photographic, For Endoscope (Exclude Light Sources) 1Camera, Cine, Endoscopic, Without Audio 1

Registration details (sample)

MarketIdentifierNameClass / date
CN京械注准20262060294电子内窥镜图像处理器Class II
CN京械注准20262060141医用内窥镜冷光源Class II
CN京械注准20262060140医用内窥镜冷光源Class II
CN京械注准20252060973医用内窥镜冷光源Class II
EU06975648372007DELONClass I
EU06975648371000DELONClass I

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