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43 device results listed.

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BIOHIT Active B12 (HoloTC)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587022901
Basic UDI-DI: B-06419587022901
Reference: 602290
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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BIOHIT Calprotectin

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587022604
Basic UDI-DI: B-06419587022604
Reference: 602260
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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BIOHIT ColonView quick test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587022505
Basic UDI-DI: B-06419587022505
Reference: 602250.02
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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BIOHIT Celiac quick test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020808
Basic UDI-DI: B-06419587020808
Reference: 602080
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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BIOHIT Celiac quick test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020709
Basic UDI-DI: B-06419587020709
Reference: 602070
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 UFT300

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020211
Basic UDI-DI: B-06419587020211
Reference: 602021
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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BIOHIT Lactase Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020181
Basic UDI-DI: B-06419587020181
Reference: 602018
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020174
Basic UDI-DI: B-06419587020174
Reference: 602017
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 quick test

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020150
Basic UDI-DI: B-06419587020150
Reference: 602015
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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Lactose Intolerance quick test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020129
Basic UDI-DI: B-06419587020129
Reference: 602012
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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Lactose Intolerance quick test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020105
Basic UDI-DI: B-06419587020105
Reference: 602010
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010403
Basic UDI-DI: B-06419587010403
Reference: 601040.02
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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Gastrin-17 Advanced

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010359
Basic UDI-DI: B-06419587010359
Reference: 601035
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

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Pepsinogen II

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010205
Basic UDI-DI: B-06419587010205
Reference: 601020.02
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Pepsinogen I

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010106
Basic UDI-DI: B-06419587010106
Reference: 601010.01
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

QC Cassette

IVD Class AIVDR 2017/746On the market

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587350004
Basic UDI-DI: 6419587QC0010PV
Reference: 740470
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

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BIOHIT FAEX Sample System

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587348001
Basic UDI-DI: 6419587BFX010TC
Reference: 602600
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

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GP Reader NT

HIT-92A

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587343006
Basic UDI-DI: 6419587RNT0103T
Reference: 740450
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

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BIOHIT Extraction tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587022703
Basic UDI-DI: 6419587BET010S5
Reference: 602270
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

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Acetium lozenge - quit smoking

Class IMDDOn the marketSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: D-620000LXA
Basic UDI-DI: B-620000LXA
Reference: 620000L
EMDN: V9017
EMDN description: ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:19

Manufacturer products View details