HomeChinaHangzhou Shanyou Medical Equipment Co.,Ltd

Hangzhou Shanyou Medical Equipment Co.,Ltd

China · 杭州 · Hangzhou Shanyou Medical Equipment Co., Ltd.
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000018226Unified social credit code 9133010973842458XP

This company holds 27 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Israel — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
27China registrations
Class I 1Class II 26
as of 2026-09-04
EUEuropean UnionEUDAMED
2UDI-DI device records
Class I 2
USUnited StatesFDA openFDA
17listed device types
Class I 16Class II 1Class III 0
plus 17 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class I 3Class IIa 4
BRBrazilANVISA
22registered devices
Class I 3Class II 19
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union2 raw hits, 0 excluded, 2 confirmed
United States17 registration records, 0 510(k), 0 PMA
China27 certificates (Class III 0 / II 26 / I 1), as of 2026-09-04
United Kingdom7 confirmed, 0 excluded
Brazil22 confirmed, 0 excluded
Manufacturer names merged into this page: HANGZHOU SHANYOU MEDICAL EQUIPMENT CO.,LTD · HANGZHOU SHANYOU MEDICAL EQUIPAMENT CO., LTDA · HANGZHOU SHANYOU MEDICAL EQUIPMENT CO. LTD. · Work – Hangzhou Shanyou Medical Equipament Co.,Ltd · Hanghzou Shanyou Medical Equipament Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000018226
EU authorised representative
Prolinx GmbH
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
9133010973842458XP
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
1
Annual revenue
RMB 100–500M
Website
Hangzhou Shanyou Medical Equipment Co., Ltd.
Product categories
医用耗材呼吸、麻醉和急救器械注输、护理和防护器械手术器械手术室及急救

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
2002-04-29
Registered capital
CNY 100,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-05-08
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based 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 listed device types

showing 8 of 17
Anesthesia Breathing Circuit Kit (Adult & Pediatric) 1Mask, Oxygen, Low Concentration, Venturi 1Stylet, Tracheal Tube 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Laryngoscope, Non-Rigid 1Set, Tubing And Support, Ventilator (W Harness) 1Cannula, Nasal, Oxygen 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20262140303重组胶原蛋白凝胶敷料Class II
CN浙械注准20262140094重组胶原蛋白贴敷料Class II
CN浙械注准20252141996一次性使用输尿管支架Class II
CN浙械注准20252021794一次性使用输尿管导引鞘Class II
EU06944746598640Endotracheal Tube HolderClass I
EU06944746598770Class I
UK35172Face Masks Class IIa
UK35142Face Masks Class IIa
UK46967Endotracheal TubesClass IIa
BR80559710006Cânula de Guedel RS MedicalClass II
BR80559710007Tubo Endotraqueal sem balão RS medicalClass II
BR80559710008Tubo Endotraqueal sem balão reforçado RS MedicalClass II

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