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EUDAMED Device Search

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Rapid Amphetamine Test Card

1L01C3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963710017
Basic UDI-DI: B-06921963710017
Reference: 1L01C3
EMDN: W0102160501
EMDN description: AMPHETAMINES - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:54

Manufacturer products Authorised representative products Authorised representative actors View details

First Sign™ One-step Drug of Abuse Test

Dipcard

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: 06909620261072
Basic UDI-DI: B-06909620261072
Reference: WH-DU-O0143T03
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Poland
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

Multi test narkotykowy

Dipcard

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: 06909620261027
Basic UDI-DI: B-06909620261027
Reference: WH-DU-S3542E03
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Poland
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy HCG test

strip

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06429830209218
Basic UDI-DI: B-06429830209218
Reference: 20260501
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Ovulation LH test

strip

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Shenzhen GLD Biotechnology Ltd.
Manufacturer SRN: CN-MF-000030045
UDI-DI: 06429830209201
Basic UDI-DI: B-06429830209201
Reference: 20260501
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Finland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

GastroPanel® quick test NT

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587602424
Basic UDI-DI: B-06419587602424
Reference: 602420
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

GastroPanel® quick test NT

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587602417
Basic UDI-DI: B-06419587602417
Reference: 602410
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

GastroPanel® quick test

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587023205
Basic UDI-DI: B-06419587023205
Reference: 602320
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 03:52

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See Now Troponin I test

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012448
Basic UDI-DI: B-05944759012448
Reference: SN 6.1
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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See Now cardiac panel (cTnI, CKMB, MYO)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012240
Basic UDI-DI: B-05944759012240
Reference: SN 6.X.3
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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See Now Fecal Occult Blood (FOB) test

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012233
Basic UDI-DI: B-05944759012233
Reference: SN 3.7
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

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Test ciążowy DUO Sanovia

DUO pregnancy test, sensitivity: 10 mIU/ml

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: DIAGNOSIS S.A.
Manufacturer SRN: PL-MF-000014187
UDI-DI: 05907581250723
Basic UDI-DI: B-05907581250723
Reference: 0033W
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:18

Manufacturer products View details

Test ciążowy strumieniowy Sanovia

Midstream pregnancy test, sensitivity: 10 mIU/ml

IVD self-testing devicesIVDDOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: DIAGNOSIS S.A.
Manufacturer SRN: PL-MF-000014187
UDI-DI: 05907581250716
Basic UDI-DI: B-05907581250716
Reference: 0032W
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:18

Manufacturer products View details

Test ciążowy płytkowy Sanovia

Cassette pregnancy test, Sensitivity: 10 mIU/ml

IVD self-testing devicesIVDDOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: DIAGNOSIS S.A.
Manufacturer SRN: PL-MF-000014187
UDI-DI: 05907581250709
Basic UDI-DI: B-05907581250709
Reference: 0020W
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:18

Manufacturer products View details

CORMAY TPHA 100

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514662593
Basic UDI-DI: B-05907514662593
Reference: 6-259
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY RPR Carbon 500

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514662562
Basic UDI-DI: B-05907514662562
Reference: 6-256
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY CRP Latex 100

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514662548
Basic UDI-DI: B-05907514662548
Reference: 6-254
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY RF Latex 100

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514662524
Basic UDI-DI: B-05907514662524
Reference: 6-252
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY ASO Latex 100

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514662517
Basic UDI-DI: B-05907514662517
Reference: 6-251
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

Teste Rápido de Gravidez (Pantest HCG Rapid Test)

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: Pantest SA
Manufacturer SRN: PT-MF-000026431
UDI-DI: 05600233273001
Basic UDI-DI: B-05600233273001
Reference: hCg03
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Portugal
Authorised representative: -
Last updated: 02.08.2026 21:51

Manufacturer products View details