HomeChinaHebei Yuanrun Medical Devices Co.,ltd.

Hebei Yuanrun Medical Devices Co.,ltd.

China · 石家庄
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000019188Unified social credit code 91130123595418405J

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
6China registrations
Class I 2Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
146UDI-DI device records
Class I 146
USUnited StatesFDA openFDA
6listed device types
Class I 6Class II 0Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class I 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
2active ARTG entries
Class I 2
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 Union146 raw hits, 0 excluded, 146 confirmed
United States6 registration records, 0 510(k), 0 PMA
China6 certificates (Class III 0 / II 4 / I 2), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Manufacturer names merged into this page: HEBEI YUANRUN MEDICAL DEVICES CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000019188
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91130123595418405J
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
41

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
2012-05-04
Registered capital
CNY 23,000,000
Paid-in capital
CNY 23,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Other manufacturing
Last approval date
2025-10-15
Recognitions
Micro and small enterpriseNational High-Tech 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 listed device types

Hearing Aid, Air-Conduction, Over The Counter 1Pack, Hot Or Cold, Disposable 1Dilator, Nasal 1Tape And Bandage, Adhesive 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Elastomer, Silicone, For Scar Management 1

Registration details (sample)

MarketIdentifierNameClass / date
CN冀械注准20242140340通气鼻贴Class II
CN冀械注准20212090544穴位贴敷治疗贴Class II
CN冀械注准20212090543磁疗热贴Class II
CN冀械注准20202090678热灸贴Class II
EU06970757003439Class I
EU06970757001657Class I
EU06970757002845Class I
EU06970757002838Class I
UK47606Nasal stripsClass I

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