Biohit Oyj

Finland · Helsinki · www.biohithealthcare.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN FI-MF-000014642

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Israel, Russia — 10 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

43UDI-DI device records

Class I 1Class IIa 1IVD A 6IVD general 35

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

20registered device records

Class I 1IVD A 3IVD general 16

BRBrazilANVISA

7registered devices

Class II 7

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

12active device licences

Class II 10Class III 2

16 including historic records

TWTaiwanTFDA

6valid device licences

Class I 3Class II 3

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

14active registrations

Class 1 4Class 2a 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 Union43 raw hits, 0 excluded, 43 confirmed

United States1 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom20 confirmed, 0 excluded

Brazil7 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: BIOHIT OYJ

Regulatory identity

EU manufacturer SRN: FI-MF-000014642
UK responsible person: BIOHIT HealthCare Ltd

Business registration

LEI: 74370089ATTSNBXJVT29
Registration status: Active
Legal form: Publikt aktiebolag (abp)
Incorporated: 1988-06-08
Registered address: LAIPPATIE 1, HELSINKI, FI-00880
Registration authority: The Business Information System (BIS), no. 0703582-0
Registry record updated: 2026-06-10

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06419587350004	QC Cassette	IVD A
EU	06419587351001	QC Cassette	IVD A
EU	06419587349008	BIOHIT FAEX Sample System	IVD A
EU	06419587348001	BIOHIT FAEX Sample System	IVD A
UK	53624	BIOHIT Calprotectin	IVD general
UK	38218	BIOHIT ColonView QT Control	IVD general
UK	54532	BIOHIT ColonView quick test	IVD general
BR	10300390788	INTOLERANCIA A LACTOSE	Class II
BR	10300390622	PEPSINOGENIO II	Class II
BR	10300390630	HELICOBACTER PYLORI TESTE RÁPIDO	Class II
CA	91934	H. PYLORI CONTROL +	Class II
CA	64436	PEPSINOGEN I EIA TEST KIT	Class II
CA	64437	PEPSINOGEN II EIA TEST KIT	Class II

Biohit Oyj

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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