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Credo Diagnostics Biomedical Pte. Ltd.

Singapore · Singapore · www.credodxbiomed.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN TW-MF-000023414

This company has registrations in European Union, United Kingdom, Taiwan, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

16UDI-DI device records

IVD A 2IVD general 14

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

13registered device records

IVD A 2IVD general 11

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

9valid device licences

Class I 9

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 Union16 raw hits, 0 excluded, 16 confirmed

United States0 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom13 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN: TW-MF-000023414
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: Advena Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719878570602	VitaSIRO solo MT-RNR1 SNP Assay	IVD general
EU	04719878570541	VitaSIRO solo HPV Assay	IVD general
EU	04719878570435	VitaPCR Flu A&B External Control Set	IVD general
EU	04719878570084	VitaPCR Flu/RSV Assay	IVD general
UK	51714	VitaPCR™ Strep A Assay	IVD general
UK	49997	VitaSIRO solo™ HPV Assay	IVD general
UK	47279	VitaPCR™ Flu A&B External Control Set	IVD general

Credo Diagnostics Biomedical Pte. Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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