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AIKANG MEDTECH CO.,LTD

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000027272Unified social credit code 91440300748898316G

This company holds 40 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets. EU UDI-DI records ≥33, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

40China registrations

Class I 25Class II 11Class III 4

as of 2026-09-04

EUEuropean UnionEUDAMED

≥33UDI-DI device records

IVD A 33

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

5listed device types

Class I 4Class II 1Class III 0

plus 5 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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 Union505 raw hits, 267 excluded, 33 confirmed. Large result set — only the first 300 verified

United States5 registration records, 0 510(k), 0 PMA

China40 certificates (Class III 4 / II 11 / I 25), as of 2026-09-04

United Kingdom0 confirmed, 2 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: AIKANG MEDTECH CO., LTD · AIKANG MEDTECH CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000027272
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code: 91440300748898316G
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2003-05-12
Registered capital: CNY 60,000,000
Paid-in capital: CNY 21,567,709
Legal form: Joint-stock limited company (unlisted)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-07-21
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseAbove-designated-size industrial enterprise

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 listed device types

Analyzer, Enzyme, For Clinical Use 1Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Refrigerator, Freezer, Blood Storage 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263220357	血型干化学胶体金联检分析仪	Class III
CN	国械注准20233221175	全自动血型分析仪	Class III
CN	国械注准20163221401	全自动血型分析仪	Class III
CN	国械注准20153221977	全自动血型分析仪	Class III
EU	06974621212743	Automated Blood Grouping Analyzer	IVD A
EU	06974621212736	Automated Blood Grouping Analyzer	IVD A
EU	06974621212729	Automated Blood Grouping Analyzer	IVD A
EU	06974621212712	Automated Blood Grouping Analyzer	IVD A
BR	80461910007	Incubadora de Cartões Reagentes	Class I
BR	83279929001	Plasma Blast Freezer	Class II

AIKANG MEDTECH CO.,LTD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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