HomeChinaHangzhou Primecare Medical Co., Ltd.

Hangzhou Primecare Medical Co., Ltd.

China · Hangzhou Zhejiang · www.primecare-medical.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000011403Unified social credit code 91330104MA2AYKDC04

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Australia — 7 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
158UDI-DI device records
Class I 156Class IIa 2
USUnited StatesFDA openFDA
28listed device types
Class I 16Class II 11Class III 0unclassified 1
plus 28 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 2
BRBrazilANVISA
4registered devices
Class I 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
40active ARTG entries
Class I 6IIa 9Class Im (measuring) 1Class Is (sterile) 24
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 Union158 raw hits, 0 excluded, 158 confirmed
United States28 registration records, 2 510(k), 0 PMA, 4 excluded
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom2 confirmed, 0 excluded
Brazil4 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Hangzhou Primecare Medical Co.,Ltd. · HANGZHOU PRIMECARE MEDICAL CO.,LTD. · HANGZHOU PRIMECARE MEDICAL CO, LTD · Hangzhou Primecare Medical Co., Ltd .

Regulatory identity

EU manufacturer SRN
CN-MF-000011403
EU authorised representative
MedPath GmbH
UK responsible person
MedPath Limited
Unified social credit code
91330104MA2AYKDC04
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Hangzhou Zhejiang
Social-insurance enrolees
25
Annual revenue
RMB 100–500M
Website
www.primecare-medical.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
2017-12-07
Registered capital
CNY 25,000,000
Paid-in capital
CNY 25,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Wholesale trade
Last approval date
2023-09-14
Recognitions
Micro and small 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

12020 · K202698
12024 · K240039

FDA listed device types

showing 8 of 28
Tracheostomy And Nasal Suctioning Kit 1Syringe, Irrigating (Non Dental) 1Container, Specimen, Sterile 1Dispenser, Liquid Medication 1Lubricant, Patient 1Kit, Surgical Instrument, Disposable 1Container, Specimen, Non-Sterile 1Device, Paste-On For Incontinence, Sterile 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04250647706230Urinary Catheterization/Collection KitsClass IIa
EU04250647704946Urinary Catheterization/Collection KitsClass IIa
EU06972360695858Enteral Feeding SetClass I
EU06972360695995Urine BagClass I
UK17541Prefilled Syringe with 10ml aqua destClass I
UK17541Prefilled Syringe with 10ml aqua dest-glycerine solutionClass I
USK240039Enteral Feeding Sets2024-04-17
USK202698Prefilled Syringe2020-12-15
BR80305560113UROSET BOLSA COLETORA DE URINAClass I
BR10216350092BOLSA COLETORA DE URINASISTEMA FECHADO PARA DRENAGEM URINÁRIA - UROZAMClass I
BR10216350095BOLSA COLETORA DE URINA SISTEMA FECHADO PARA DRENAGEM URINÁRIA - UROZAClass I
SAME0000005790SFDAA00005Enema Set

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