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Wuhan EasyDiagnosis Biomedicine Co., Ltd

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000019908

This company has registrations in European Union, Brazil, Israel, Russia — 4 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

≥300UDI-DI device records

IVD C 63IVD general 223ivd-devices-self-testing 14

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

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

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

7registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 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 Union421 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: WUHAN EASYDIAGNOSIS BIOMEDICINE CO. LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000019908
EU authorised representative: OSMUNDA Medical Technology Service GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06978896417711	COVID-19(SARS-CoV-2) Antigen Test Kit	ivd-devices-self-testing
EU	06978896417704	COVID-19(SARS-CoV-2) Antigen Test Kit	ivd-devices-self-testing
EU	06978896417698	COVID-19(SARS-CoV-2) Antigen Test Kit	ivd-devices-self-testing
EU	06978896417681	COVID-19(SARS-CoV-2) Antigen Test Kit	ivd-devices-self-testing
BR	82195300020	ANALISADOR DE GASES SANGUÍNEOS PT1000	Class II

Wuhan EasyDiagnosis Biomedicine Co., Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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