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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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979 device results listed.

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FluoroType® HLA-B27 VER 1.0

FluoroType® HLA-B27 VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003013
Basic UDI-DI: B-04049055003013
Reference: 60896
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

FluoroType® MTHFR C677T VER 1.0

FluoroType® MTHFR C677T VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002795
Basic UDI-DI: B-04049055002795
Reference: 60024
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

FluoroType® LCT VER 1.0

FluoroType® LCT VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002757
Basic UDI-DI: B-04049055002757
Reference: 60424
EMDN: W0106010402
EMDN description: LACTOSE INTOLERANCE (POLYMORPHISMS)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

FluoroType® HH H63D VER 1.0

FluoroType® HH H63D VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002719
Basic UDI-DI: B-04049055002719
Reference: 60724
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

FluoroType® HH C282Y VER 1.0

FluoroType® HH C282Y VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002696
Basic UDI-DI: B-04049055002696
Reference: 60624
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

FluoroType® Factor V VER 1.0

FluoroType® Factor V VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002689
Basic UDI-DI: B-04049055002689
Reference: 60396
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

FluoroType® Factor II VER 1.0

FluoroType® Factor II VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002665
Basic UDI-DI: B-04049055002665
Reference: 60296
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

ThromboType®plus VER 3.0

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

ThromboType® VER 2.0

ThromboType® VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055001125
Basic UDI-DI: B-04049055001125
Reference: 24196
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

ThromboType® VER 2.0

ThromboType® VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055001118
Basic UDI-DI: B-04049055001118
Reference: 241
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType IL-1 VER 1.0

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

GenoType PAI-1 VER 2.0

GenoType PAI-1 VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000432
Basic UDI-DI: B-04049055000432
Reference: 222
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType MTHFR VER 3.0

GenoType MTHFR VER 3.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000364
Basic UDI-DI: B-04049055000364
Reference: 252
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType LCT VER 1.0

GenoType LCT VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000258
Basic UDI-DI: B-04049055000258
Reference: 261
EMDN: W0106010402
EMDN description: LACTOSE INTOLERANCE (POLYMORPHISMS)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType ApoE VER 1.0

GenoType ApoE VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000111
Basic UDI-DI: B-04049055000111
Reference: 350
EMDN: W0106010499
EMDN description: POLYMORPHISM 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 DM1 Dx Kit

AmplideX DM1 Dx Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00863840000261
Basic UDI-DI: B-00863840000261
Reference: 76048
EMDN: W0106010118
EMDN description: MYOTONIC DYSTROPHY TYPE 1 OR STEINERT'S DISEASE
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

QuantideX qPCR BCR-ABL minor Kit

QuantideX qPCR BCR-ABL minor Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00863840000230
Basic UDI-DI: B-00863840000230
Reference: 49640
EMDN: W0106010299
EMDN description: POLYGENETIC 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

HT111

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Silver Lake Research Corporation
Manufacturer SRN: US-MF-000027373
UDI-DI: 00850031753020
Basic UDI-DI: B-00850031753020
Reference: HT111
EMDN: W0106010109
EMDN description: SICKLE CELL ANEMIA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

AmplideX mPCR FMR1 Test

AmplideX mPCR FMR1 Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493049
Basic UDI-DI: B-00850017493049
Reference: A00401
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details