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CORIS BIOCONCEPT SRL

✓ Record-verifiedregistrations found in 8 marketsEU SRN BE-MF-000024520

This company has registrations in European Union, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 8 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

6UDI-DI device records

IVD A 2IVD B 2IVD general 2

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

25registered device records

IVD A 2IVD general 23

BRBrazilANVISA

1registered devices

Class II 1

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

14active device licences

Class II 14

18 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union6 raw hits, 0 excluded, 6 confirmed

United Kingdom25 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: CORIS BIOCONCEPT · CORIS BIOCONCEPT SPRL

Regulatory identity

EU manufacturer SRN: BE-MF-000024520
UK responsible person: Launch Diagnostics Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	15420071900603	RESIST-3 O.K.N. Carbapenemases rapid test	IVD B
EU	15420071901006	RESIST-1 MCR Multi Mobilised colistin resistance rapid test	IVD general
EU	15420071900993	RESIST-1 MCR Multi Mobilised colistin resistance rapid test	IVD general
EU	15420071900702	RESIST-5 O.K.N.V.I. Carbapenemases rapid test	IVD B
UK	49861	ADENOVIRUS POSITIVE CONTROL	IVD general
UK	49856	ADENO RESPI K-SET	IVD general
UK	42733	BL-RED 25	IVD general
BR	80826840096	Rota-Strip	Class II
CA	33088	CRYPTO-STRIP	Class II
CA	33089	ROTA-STRIP	Class II
CA	33091	40/41 ADENO-STRIP	Class II

CORIS BIOCONCEPT SRL

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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