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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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Active filter:Manufacturer SRN:US-MF-000011830

7 device results listed.

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AmplideX Fragile X Dx & Carrier Screen Kit

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493124
Basic UDI-DI: 0850017493A011248A
Reference: A01124
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:15

Manufacturer products Authorised representative products Authorised representative actors 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

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