HomeChinaSHANDONG ZHENFU MEDICAL DEVICES CO., LTD

SHANDONG ZHENFU MEDICAL DEVICES CO., LTD

China · 日照 · www.zhenfugroup.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000031319Unified social credit code 91371102779731586G

This company holds 10 NMPA certificates in China and has registrations in European Union, United Kingdom, Brazil, Australia, Israel — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 5Class II 3Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
67UDI-DI device records
Class I 47Class IIa 20
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 2
BRBrazilANVISA
19registered devices
Class I 1Class II 18
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
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 Union67 raw hits, 0 excluded, 67 confirmed
China10 certificates (Class III 2 / II 3 / I 5), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Brazil19 confirmed, 0 excluded
Manufacturer names merged into this page: SHANDONG ZHENFU MEDICAL DEVICE CO, LTD · SHANDONG ZHENFU MEDICAL APPLIANCE CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000031319
EU authorised representative
Eunitor GmbH
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91371102779731586G
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
97
Annual revenue
RMB 30–50M
Website
www.zhenfugroup.com
Product categories
呼吸、麻醉和急救器械医用成像器械注输、护理和防护器械输血、透析和体外循环器械

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
2005-09-06
Registered capital
CNY 13,690,000
Paid-in capital
CNY 13,690,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2020-05-27
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle enterpriseRecognised enterprise technology centre

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20173144490一次性使用精密药液过滤器Class III
CN国械注准20173144487一次性使用精密过滤输液器 带针Class III
CN鲁械注准20252080735一次性使用热湿交换过滤器Class II
CN鲁械注准20242080504一次性使用呼吸过滤器Class II
EU16970529950814Pulmonary function test filter Class IIa
EU16970529957257Oxygen concentrator filterClass I
EU16970529957240Oxygen concentrator filterClass I
EU16970529957233Oxygen concentrator filterClass I
UK60837Essential Insufflation Filter/Tubing SetClass I
UK31723Essential Smoke FilterClass I
BR81908729009Filtro HMEFClass II
BR83147119001Filtro HMEF CMEXClass II
BR80239549002Filtro HMEF Polimax Medical CareClass II

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