Reagena Oy

✓ Record-verifiedregistrations found in 3 marketsEU SRN FI-MF-000002804

This company has registrations in European Union, United Kingdom, Russia — 3 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

50UDI-DI device records

IVD A 36IVD B 2IVD general 12

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

7registered device records

IVD A 1IVD general 6

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 Union50 raw hits, 0 excluded, 50 confirmed

United Kingdom7 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: FI-MF-000002804
UK responsible person: Invitech Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06430074450915	Formalin 10 % in sample container (2500 ml), phosphate buffered pH 7,2 incl. 4 % formaldehyde	IVD A
EU	06430074452452	ReaScan+ PUUMALA IgM	IVD B
EU	06430074452469	ReaScan TBE IgM	IVD B
EU	06430074452773	Formalin 10 % in sample container with spoon (94 x 8 ml), phosphate buffered pH 7.2 incl. 4 % formaldehyde	IVD A
UK	43587	ReaStain	IVD general
UK	65281	ReaScan+	IVD general
UK	50568	Reagena C6 Lyme IgM/IgG EIA	IVD general

Reagena Oy

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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