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141 device results listed.

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GenoType CVD VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003044
Basic UDI-DI: B-04049055003044
Reference: 33512
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

ThromboType®plus VER 3.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055001149
Basic UDI-DI: B-04049055001149
Reference: 341
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType IL-1 VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000456
Basic UDI-DI: B-04049055000456
Reference: 5001
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

AmplideX SMA Plus Kit (50 rxn)

AmplideX SMA Plus Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00863840000278
Basic UDI-DI: B-00863840000278
Reference: A00055
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

AmplideX SMA Plus Kit (100 rxn)

AmplideX SMA Plus Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493025
Basic UDI-DI: B-00850017493025
Reference: A00056
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MTHFR Mutation Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930542
Basic UDI-DI: 89080153043B1331KY
Reference: 3B1331/C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HLA B-27 Real-Time PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930450
Basic UDI-DI: 89080153043B247NM
Reference: 3B247/C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

37350134361787

SPOT-it TREC & SMN1 Screening Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361787
Basic UDI-DI: 7350134361789C
Reference: 4-2020-TS
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:12

Manufacturer products View details

SALSA MLPA Probemix P044 NF2