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06.07.2026 17:14

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78 device results listed.

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GenoType HelicoDR VER 1.0

GenoType HelicoDR VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055001217
Basic UDI-DI: B-04049055001217
Reference: 337
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
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

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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

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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

micro-IDent® VER 2.0

micro-IDent® VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000531
Basic UDI-DI: B-04049055000531
Reference: 23296
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

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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 Mycobacterium CM VER 2.0

GenoType Mycobacterium CM VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000425
Basic UDI-DI: B-04049055000425
Reference: 29996A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType Mycobacterium CM VER 2.0

GenoType Mycobacterium CM VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000418
Basic UDI-DI: B-04049055000418
Reference: 299A
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType Mycobacterium AS VER 1.0

GenoType Mycobacterium AS VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000395
Basic UDI-DI: B-04049055000395
Reference: 298
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
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 MTBC VER 1.X

GenoType MTBC VER 1.X

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000319
Basic UDI-DI: B-04049055000319
Reference: 301
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

GenoType MRSA VER 3.0

GenoType MRSA VER 3.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000272
Basic UDI-DI: B-04049055000272
Reference: 30512
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
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

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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

LiquidArray® Gastrointestinal VER 2.0

LiquidArray® Gastrointestinal VER 2.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003990
Basic UDI-DI: 40490550300001110TX
Reference: 1910680
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

Analyzer GENERIC HBV VL 2.0 FCXT

Analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003945
Basic UDI-DI: 40490550300001109UE
Reference: 1901991
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

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FluoroType® MTBDR VER 2.0

FluoroType® MTBDR VER 2.0

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003938
Basic UDI-DI: 40490550300001005TZ
Reference: 62896
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

Liquefaction Set VER 1.0

Liquefaction Set VER 1.0

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003921
Basic UDI-DI: 40490550300001107UA
Reference: 1896574
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

GENERIC HIV-1 VIRAL LOAD VER 2.0

GENERIC HIV-1 VIRAL LOAD VER 2.0

IVD Class DIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003907
Basic UDI-DI: 40490550300001105U6
Reference: TR001.2-192
EMDN: W0105030107
EMDN description: HIV 1 - NA REAGENTS
First on market country: Germany
Safety summary (SSCP/SSP): FM-047000 · Rev. 04
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products Open in EUDAMED View details