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970 device results listed.

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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

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

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

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

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

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

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

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

HemoTypeSC

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

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

AmplideX HTT SNP/Repeat Phasing Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493032
Basic UDI-DI: B-00850017493032
Reference: A00083
EMDN: W0106010107
EMDN description: HUNTINGTON CHOREA
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

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

D-00106010104013V8

FMR1 CGG PCR

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-00106010104013V8
Basic UDI-DI: B-00106010104013V8
Reference: 50 Tests/Kit
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 04.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

gb GENETIC APOE

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223920621
Basic UDI-DI: 85952239000003WY
Reference: 3206-50
EMDN: W0106010203
EMDN description: ATHEROSCLEROSIS
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 22:47

Manufacturer products View details

TRUPCR® MGMT Methylation Detection Kit

3B1339

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304217
Basic UDI-DI: 89080153043B1339LG
Reference: 3B1339
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304088
Basic UDI-DI: 89080153043B1267LG
Reference: 3B1267
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® IDH1/2 Detection & Differentiation Kit

3B1338

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304033
Basic UDI-DI: 89080153043B1338LE
Reference: 3B1338
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL1 Minor Quantitative Kit

IVD Class CIVDR 2017/746On the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304026
Basic UDI-DI: 89080153043B1291LD
Reference: 3B1291
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

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