HomeChinaShenzhen Anke High-tech Co., Ltd.

Shenzhen Anke High-tech Co., Ltd.

China · 深圳 · www.anke.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000016473Unified social credit code 91440300618808351X

This company holds 29 NMPA certificates in China and has registrations in European Union, United States, Taiwan, Russia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
29China registrations
Class II 7Class III 22
as of 2026-09-04
EUEuropean UnionEUDAMED
23UDI-DI device records
Class IIa 4Class IIb 19
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(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
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
10active registrations
Class 2a 4Class 2b 6
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 Union98 raw hits, 75 excluded, 23 confirmed
United States0 registration records, 1 510(k), 0 PMA, 1 excluded
China29 certificates (Class III 22 / II 7 / I 0), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN
CN-MF-000016473
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91440300618808351X
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
347
Annual revenue
over RMB 500M
Website
www.anke.com
Product categories
医用成像器械

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
1986-12-31
Registered capital
CNY 158,000,000
Paid-in capital
CNY 158,000,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-05-20
Recognitions
National High-Tech EnterpriseInnovative SMEAbove-designated-size industrial 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

12012 · K113281

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263011699神经外科手术导航定位系统Class III
CN国械注准20253060878超导磁共振成像系统Class III
CN国械注准20243061394X射线计算机体层摄影设备Class III
CN国械注准20243060508X射线计算机体层摄影设备Class III
EU06950743802161Class IIb
EU06950743802154Class IIb
EU06950743802147Class IIb
EU06950743801034Class IIa
USK113281MRI SYTEMS2012-05-17

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