HomeChinaWeihai Shengjie Medical Technology Co., Ltd.

Weihai Shengjie Medical Technology Co., Ltd.

China · Weihai · www.whshengjie.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000032283Unified social credit code 91371000266325566R

This company holds 33 NMPA certificates in China and has registrations in European Union, United States, United Kingdom — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
33China registrations
Class I 18Class II 13
as of 2026-09-04
EUEuropean UnionEUDAMED
14UDI-DI device records
Class IIa 14
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIb 1
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
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 Union14 raw hits, 0 excluded, 14 confirmed
United States1 registration records, 1 510(k), 0 PMA, 1 excluded
China33 certificates (Class III 0 / II 13 / I 18), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Manufacturer names merged into this page: WEIHAI SHENGJIE MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000032283
EU authorised representative
Caretechion GmbH
UK responsible person
MedPath Limited
Unified social credit code
91371000266325566R
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Weihai
Social-insurance enrolees
85
Website
www.whshengjie.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentENT & audiology

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
1996-12-24
Registered capital
CNY 18,000,000
Paid-in capital
CNY 17,130,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2026-08-05
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseGazelle enterprise

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 · K221777

FDA listed device types

Catheter, Nasal, Oxygen 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20192140160医用外科口罩Class II
CN鲁械注准20182080040雾化面罩Class II
CN鲁械注准20172140643一次性使用无菌护理包Class II
CN鲁械注准20162140560一次性使用介入配置包Class II
EU06970614670255Class IIa
EU06970614670248Class IIa
EU06970614670231Class IIa
EU06970614670224Class IIa
UK35457Nebulizer Kits Class IIb
USK221777Disposable Sterile Syringe2023-10-06

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