HomeChinaShaanxi Ansen Medical Technology Development Co.,Ltd

Shaanxi Ansen Medical Technology Development Co.,Ltd

China · 西安 · www.4000298818.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000050669Unified social credit code 91610000745031071F

This company holds 8 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
8China registrations
Class I 7Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
35UDI-DI device records
Class I 35
USUnited StatesFDA openFDA
7listed device types
Class I 7Class II 0Class III 0
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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 Union43 raw hits, 8 excluded, 35 confirmed
United States7 registration records, 0 510(k), 0 PMA, 2 excluded
China8 certificates (Class III 0 / II 1 / I 7), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Manufacturer names merged into this page: SHAANXI ANSEN MEDICAL TECHNOLOGY DEVELOPMENT CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000050669
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Unified social credit code
91610000745031071F
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
134
Annual revenue
RMB 30–50M
Website
www.4000298818.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
2003-02-20
Registered capital
CNY 20,000,000
Paid-in capital
CNY 20,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-07-01
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based 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

Bandage, Cast 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Cover, Cast 1Component, Cast 1Tape, Orthopedic 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Splint, Traction 1

Registration details (sample)

MarketIdentifierNameClass / date
CN陕械注准20252040027电池供电骨组织手术设备Class II
CN陕西械备20240067号骨科用锯片Class I
CN陕西械备20240066号骨科用电锯片Class I
CN陕西械备20240065号骨科电钻头Class I
EU06970210232567Fiberglass SplintClass I
EU06970210232550Fiberglass SplintClass I
EU06970210232543Fiberglass SplintClass I
EU06970210232536Fiberglass SplintClass I

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