HomeChinaZhejiang Hfizer Medical Equipment Co, LTD

Zhejiang Hfizer Medical Equipment Co, LTD

China · 金华 · www.hfizer.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000036362Unified social credit code 91330784MA7LJ8NF3T

This company holds 5 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
5China registrations
Class I 1Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
5UDI-DI device records
Class I 5
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 4 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 3
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 Union5 raw hits, 0 excluded, 5 confirmed
United States4 registration records, 2 510(k), 0 PMA
China5 certificates (Class III 0 / II 4 / I 1), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded
Manufacturer names merged into this page: ZHEJIANG HFIZER MEDICAL EQUIPMENT CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000036362
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91330784MA7LJ8NF3T
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
11
Annual revenue
RMB 10–30M
Website
www.hfizer.com
Product categories
养老用品

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
2022-04-14
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Other manufacturing
Last approval date
2026-04-08
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

22024 · K242136

FDA listed device types

Wheelchair, Powered 1Chair, Positioning, Electric 1Walker, Mechanical 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20232191929电动轮椅车Class II
CN浙械注准20232191928电动轮椅车Class II
CN浙械注准20232191420手动轮椅车Class II
CN浙械注准20232191419手动轮椅车Class II
EU06976498000119Class I
EU06976498000218Class I
EU06976498000126 JNKYDClass I
EU06976498000072JNKYDClass I
UK40747Rollator WalkersClass I
UK41875Electric WheelchairClass I
UK41875Rollator WalkersClass I
USK242136Electric wheelchair (C001)2024-09-12
USK240673Electric wheelchair2024-06-20

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