HomeChinaHangzhou Fushan Medical Appliances Co., Ltd

Hangzhou Fushan Medical Appliances Co., Ltd

China · Hangzhou Zhejiang · www.fushanhz.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000022768Unified social credit code 913301857766107466

This company holds 20 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥200, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
20China registrations
Class II 20
as of 2026-09-04
EUEuropean UnionEUDAMED
≥200UDI-DI device records
Class IIa 200
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
44listed device types
Class I 29Class II 15Class III 0
plus 40 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 1
BRBrazilANVISA
28registered devices
Class I 2Class II 26
29 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
13active ARTG entries
Class I 1IIa 10Class Is (sterile) 2
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union2,985 raw hits, 0 excluded, 200 confirmed. Large result set — only the first 300 verified
United States40 registration records, 0 510(k), 0 PMA
China20 certificates (Class III 0 / II 20 / I 0), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Brazil28 confirmed, 0 excluded
Manufacturer names merged into this page: Hangzhou Fushan Medical Appliance Co., Ltd. · HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD. · HANGZHOU FUSHAN MEDICAL APPLIANCES CO. LTD. · FUSHAN MEDICAL APPLIANCES CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000022768
EU authorised representative
SUNGO Europe B.V.
UK responsible person
P3 Medical Ltd
Unified social credit code
913301857766107466
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Hangzhou Zhejiang
Social-insurance enrolees
272
Annual revenue
RMB 50–100M
Website
www.fushanhz.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
2005-07-06
Registered capital
CNY 8,128,125
Paid-in capital
CNY 8,128,125
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-03-13
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI 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 listed device types

showing 8 of 44
Catheter, Drainage, Intraoral/Extraoral 1Protector, Ostomy 1Stapler, Skin 1Adaptor, Ureteral Catheter 1Bedding, Disposable, Medical 1Operating Room Accessories Table Tray 1Pump, Breast, Non-Powered 1Stylet, Tracheal Tube 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20262060069图像处理器Class II
CN浙械注准20252081620一次性使用加强型气管插管Class II
CN浙械注准20252081589一次性使用可视支气管堵塞器包Class II
CN浙械注准20252061822电子图像处理器Class II
EU06953676322843Drainage Tube and AccessoriesClass IIa
EU06953676320764Drainage Tube and AccessoriesClass IIa
EU06953676337069Drainage Tube and AccessoriesClass IIa
EU06953676320757Drainage Tube and AccessoriesClass IIa
UK45036P3 Larygeal MaskClass IIa
BR10150470498Dreno Torácico FoyomedClass II
BR81440809003KIT BioTube-PEG® (PULL) LUXURYClass II
BR10150470657Dreno para sucção de Tórax em PVC FoyomedClass II

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