HomeChinaHebei Pioneer Medical Instrument Co.,Ltd.

Hebei Pioneer Medical Instrument Co.,Ltd.

China · 衡水
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000039247Unified social credit code 91131181MA0A85L15K

This company holds 23 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
23China registrations
Class I 18Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
6UDI-DI device records
Class I 6
USUnited StatesFDA openFDA
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 1
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 Union22 raw hits, 16 excluded, 6 confirmed
United States0 registration records, 2 510(k), 0 PMA, 21 excluded
China23 certificates (Class III 0 / II 5 / I 18), as of 2026-09-04
United Kingdom0 confirmed, 3 excluded
Brazil1 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: HEBEI PIONEER MEDICAL INSTRUMENT CO. LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000039247
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
91131181MA0A85L15K
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
15
Annual revenue
RMB 5–10M

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
2018-05-29
Registered capital
CNY 5,000,000
Legal form
Limited liability company (wholly owned by a natural person)
Industry classification
Furniture manufacturing
Last approval date
2023-12-12
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

21992 · K914220

Registration details (sample)

MarketIdentifierNameClass / date
CN冀械注准20262150155电动护理床Class II
CN冀械注准20262150154电动病床Class II
CN冀械注准20212090369颈腰椎牵引床Class II
CN冀械注准20212090368颈椎牵引椅Class II
EU06977099380068Class I
EU06977099380051Class I
EU06977099380037Class I
EU06977099380020Class I
USK914220PIONEER PRO-PUMP1992-03-04
USK914241PIONEER PRO-PUMP DUAL CONTROL1992-03-04
BR82530260023Cadeira de Transferência e Posicionamento LONGEVITECHClass I

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