HomeChinaQingdao Zhixing Medical Instrument Co.,Ltd.

Qingdao Zhixing Medical Instrument Co.,Ltd.

China · 青岛 · www.zhixingmed.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000024667Unified social credit code 91370203MA3CFER64Q

This company holds 36 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
36China registrations
Class I 31Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
169UDI-DI device records
Class I 169
USUnited StatesFDA openFDA
6listed device types
Class I 6Class II 0Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
19registered devices
Class I 4Class II 15
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 Union169 raw hits, 0 excluded, 169 confirmed
United States6 registration records, 0 510(k), 0 PMA
China36 certificates (Class III 0 / II 4 / I 31), as of 2026-09-04
Brazil19 confirmed, 0 excluded
Manufacturer names merged into this page: QINGDAO ZHIXING MEDICAL INSTRUMENT CO., LTD. · QINGDAO ZHIXING MEDICAL INSTRUMENT CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000024667
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Unified social credit code
91370203MA3CFER64Q
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.zhixingmed.com
Product categories
手术室及急救

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
2016-08-17
Registered capital
CNY 6,129,207
Paid-in capital
CNY 6,129,207
Legal form
Joint-stock limited company (unlisted)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-12-02
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SME

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

Passer 1Rongeur 1Forceps 1Accessories, Arthroscopic 1Retractor 1Table And Attachments, Operating-Room 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20262020307椎间孔镜手术器械Class II
CN鲁械注准20222040469软组织过线器Class II
CN鲁械注准20212040877关节镜用手术钳Class II
CN鲁械注准20202020101脊柱内窥镜手术器械Class II
EU06973486984031BRAZO SURGICAL POSITIONERClass I
EU06973486984048BRAZO BEACH CHAIR ADAPTER Class I
EU06973486984055 BRAZO LATERAL DECUBITUS ADAPTERClass I
EU06973486984062BRAZO LEG ADAPTERClass I
BR80769979018Agulha de Passagem de Sutura OrtoMedicalClass II
BR80940199001KIT UBE DE INSTRUMENTAIS PARA ENDOSCOPIA DE COLUNA MEDICALClass II
BR80940199002KIT DE INSTRUMENTAIS PARA ENDOSCOPIA DE COLUNA MEDICALClass II

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