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Autobio Diagnostics Co., Ltd.

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000003348

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Russia — 6 overseas markets. EU UDI-DI records ≥173, 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

≥173UDI-DI device records

IVD A 17IVD B 44IVD C 90IVD general 22

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

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

119registered device records

IVD A 12IVD B 3IVD C 20IVD D 6IVD general 76IVD Annex II List B 2

BRBrazilANVISA

77registered devices

Class I 22Class II 55

140 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

98active registrations

Class 1 4Class 2a 54Class 2b 30Class 3 10

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 Union793 raw hits, 127 excluded, 173 confirmed. Large result set — only the first 300 verified

United States1 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom119 confirmed, 1 excluded

Brazil77 confirmed, 1 excluded

Manufacturer names merged into this page: AUTOBIO DIAGNOSTICS CO., LTD. · AUTOBIO DIAGNOSTICS CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000003348
EU authorised representative: QbD RepS BV
UK responsible person: Qarad UK Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06942359551496	Aldosterone CLIA Microparticles	IVD B
EU	06942359551519	Aldosterone CLIA Microparticles	IVD B
EU	06942359546386	IA-2A CLIA Microparticles	IVD C
EU	06942359546362	IA-2A CLIA Microparticles	IVD C
UK	58346	17a-OHP CLIA Microparticles	IVD general
UK	54055	ACTH CLIA Microparticles	IVD general
UK	62344	Aldosterone CLIA Microparticles	IVD general
BR	80102513197	Família AutoLumo PRL Micropartículas (CLIA)	Class II
BR	80102513641	Frasco para cultura aeróbica SA	Class I
BR	80102513642	Frasco para cultura micobacteriana	Class I

Autobio Diagnostics Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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