HomeChinachangzhou ankang medical instruments co., ltd.

changzhou ankang medical instruments co., ltd.

China · 常州 · www.akyl.cc
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91320412551197911C

This company holds 39 NMPA certificates in China and has registrations in United States, Brazil, Israel — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
39China registrations
Class I 3Class II 31Class III 5
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
7registered devices
Class II 7
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
1registrations
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 Union1,237 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States1 registration records, 1 510(k), 0 PMA, 1 excluded
China39 certificates (Class III 5 / II 31 / I 3), as of 2026-09-04
United Kingdom0 confirmed, 2 excluded
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: CHANGZHOU ANKANG MEDICAL INSTRUMENTS CO., LTD.

Regulatory identity

Unified social credit code
91320412551197911C
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
204
Annual revenue
RMB 100–500M
Website
www.akyl.cc
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
2010-03-04
Registered capital
CNY 12,188,571
Paid-in capital
CNY 12,188,571
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-07-21
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseRecognised enterprise technology centre

Business registration data from Tianyancha, as of 2026-09-03. 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

12023 · K231042

FDA listed device types

Stapler, Skin 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253022475一次性使用腔镜用直线型切割吻合器及组件Class III
CN国械注准20253012684一次性使用电动直线型切割吻合器及钉仓组件Class III
CN国械注准20243010260一次性使用电动腔镜切割吻合器及组件Class III
CN国械注准20243010143一次性使用超声软组织手术刀头Class III
USK231042Disposable Laparoscopic Trocar2023-06-08
BR80786949020Cânula de Extração de Órgãos e Espécimes PHBR MEDICALClass II
BR80786949015KIT CÂNULA TROCARTE PARA VIDEOCIRURGIA DESCARTÁVEL COM LÂMINA PHBR MEDClass II
BR80786949016KIT CÂNULA TROCARTE PARA VIDEOCIRURGIA DESCARTÁVEL SEM LÂMINA PHBR MEDClass II

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