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AK Medical

China · 北京

✓ Record-verifiedregistrations found in 5 marketsUnified social credit code 91110114750144214X

This company holds 98 NMPA certificates in China and has registrations in United States, United Kingdom, South Korea, Hong Kong — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

98China registrations

Class I 24Class II 8Class III 66

as of 2026-09-04

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

56registered device records

Class I 32Class III 24

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class III 1

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 Union54,015 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States2 registration records, 1 510(k), 0 PMA, 2 excluded

China98 certificates (Class III 66 / II 8 / I 24), as of 2026-09-04

United Kingdom56 confirmed, 131 excluded

Manufacturer names merged into this page: BEIJING AK MEDICAL CO, LTD

Regulatory identity

UK responsible person: JRI Orthopaedics Ltd
Unified social credit code: 91110114750144214X
Exhibition record: CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2003-05-08
Registered capital: CNY 100,000,000
Paid-in capital: CNY 100,000,000
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-06-25
Recognitions: National High-Tech EnterpriseSRDI SMEGazelle enterpriseRecognised enterprise technology centreAbove-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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263131516	金属增材制造匹配式长段骨缺损修复体	Class III
CN	国械注准20263130957	患者匹配式金属锁定接骨板	Class III
CN	国械注准20263130956	增材制造自稳型人工椎体系统	Class III
CN	国械注准20263130364	金属增材制造椎体融合器	Class III
UK	32848	Acetabular Reamer 38mm	Class I
UK	43167	AK-AC-I-TP Acetabular Cup with Liner 42/22	Class III
UK	58480	Buttress Trial (BTS-II) 58CL	Class I
US	K180493	A3 Total Knee System	2018-06-22

AK Medical

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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