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EUDAMED Device Search

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AFIAS Vitamin D Neo

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041314
Basic UDI-DI: 880613300598D7
Reference: SMFP-108
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Cortisol

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041154
Basic UDI-DI: 880613300520C2
Reference: SMFP-22
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

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AFIAS Testosterone

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133040997
Basic UDI-DI: 880613300519CH
Reference: SMFP-29
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

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Laboquick

LBOV.01

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Manufacturer SRN: TR-MF-000032257
UDI-DI: 08699195610297
Basic UDI-DI: 8699195610LBOV.015Q
Reference: LBOV.01
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:41

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Laboquick

LBHG.01

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Manufacturer SRN: TR-MF-000032257
UDI-DI: 08699195610037
Basic UDI-DI: 869919561003LBHG.014V
Reference: LBHG.01
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:41

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CAT Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DCA-R1023B
Basic UDI-DI: B-DCA-R1023B
Reference: DCA-R102
EMDN: W0102080401
EMDN description: CAFFEINE
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity c Myoglobin Reagent Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070962
Basic UDI-DI: 8436003070498Y7
Reference: 01R1523
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:43

Manufacturer products View details

Quantia Myoglobin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070955
Basic UDI-DI: 8436003070511X6
Reference: 6L32-44
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:43

Manufacturer products View details

CanAg Glypican-3 EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140593
Basic UDI-DI: 7350066140599R
Reference: 503-10
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:24

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AMH Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140579
Basic UDI-DI: 7350066140579M
Reference: 660-20
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:24

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HE4 EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140302
Basic UDI-DI: 7350066140308Z
Reference: 404-10
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:24

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CanAg Free PSA EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140203
Basic UDI-DI: 7350066140208W
Reference: 350-10
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:15

Manufacturer products View details

CanAg PSA EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140173
Basic UDI-DI: 73500661401799
Reference: 340-10
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:15

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CYFRA 21-1 EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140135
Basic UDI-DI: 7350066140138Z
Reference: 211-10
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:15

Manufacturer products View details

Multi-Drugs Test Panel(Urine)

DOA-1x4a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910581
Basic UDI-DI: 69798909110042CT
Reference: DOA-1x4a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 5 Drugs Test Panel(Urine)

DOA-154a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910567
Basic UDI-DI: 69798909110060CV
Reference: DOA-154a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 4 Drugs Test Panel(Urine)

DOA-144a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910574
Basic UDI-DI: 69798909110059DC
Reference: DOA-144a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 6 Drugs Test Panel(Urine)

DOA-164a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910550
Basic UDI-DI: 69798909110061CX
Reference: DOA-164a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 7 Drugs Test Panel(Urine)

DOA-174a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910543
Basic UDI-DI: 69798909110062CZ
Reference: DOA-174a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 8 Drugs Test Panel(Urine)

DOA-184a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910536
Basic UDI-DI: 69798909110063D3
Reference: DOA-184a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details