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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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07.07.2026 07:14

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675 device results listed.

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BACTICARD NEISSERIA

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022470
Basic UDI-DI: 8488380BctCrdNeisseriaBV
Reference: R21110
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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BACTICARD E. COLI

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022456
Basic UDI-DI: 8488380BctCrdEcoliHQ
Reference: R21108
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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BACTICARD CANDIDA

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022432
Basic UDI-DI: 8488380BactiCardCandida8B
Reference: R21106
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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HIPPURATE DISK

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022333
Basic UDI-DI: 8488380HippurateDiskTV
Reference: R21085
EMDN: W0104080208
EMDN description: SINGLE TESTS (DISCS, STRIPS, DROPPERS...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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COAGULASE PLASMA 5ML

COAGULASE PLASMA

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022227
Basic UDI-DI: 8488380CoagulasePlasmaLJ
Reference: R21050
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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MICROTEST M5 (3 ML) TRADITIONAL SWAB KIT PK/100

MICROTEST M5 KIT

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838018442
Basic UDI-DI: 8488380M5KitA2
Reference: R12555
EMDN: W0104010203
EMDN description: TRANSPORT MEDIA
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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MICROTEST M5 (3 ML) PK/72

MICROTEST M5

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838018350
Basic UDI-DI: 8488380M5Y4
Reference: R12515
EMDN: W0104010203
EMDN description: TRANSPORT MEDIA
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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SENSITITRE DEMINERALIZED WATER

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838011177
Basic UDI-DI: 8488380DeminWaterUP
Reference: T3339
EMDN: W0104080113
EMDN description: OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

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MICROTEST M4RT (3ML) TUBE PK/72

MICROTEST M4RT

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00842558107004
Basic UDI-DI: 8488380M4RTA3
Reference: R12587
EMDN: W0104010203
EMDN description: TRANSPORT MEDIA
First on market country: -
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:20

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MICROTEST M4RT (3ML) FLOCKED SWAB KIT PK/100

MICROTEST M4RT KIT

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00842558106939
Basic UDI-DI: 8488380M4RTKitEB
Reference: R12588
EMDN: W0104010203
EMDN description: TRANSPORT MEDIA
First on market country: -
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:20

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WELLCOGEN EDTA SOLUTION

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080502076
Basic UDI-DI: 50560805WellcoEDTAAY
Reference: R30164501
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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STREPTEX DISPOSABLE REACTION CARDS

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501550
Basic UDI-DI: 50560805StreptexCardM4
Reference: R30368601
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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Staphaurex Disposable Reaction Cards (50 cards per pack)

STAPHAUREX DISPOSABLE REACTION CARDS

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501543
Basic UDI-DI: 50560805StapharexCardsBK
Reference: R30369001
EMDN: W0104080399
EMDN description: IMMUNOLOGICAL IDENTIFICATION - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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Staphaurex Plus Latex Agglutination Test (150 tests)

STAPHAUREX PLUS LATEX AGGLUTATION TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501512
Basic UDI-DI: 50560805StapharexPlusC6
Reference: R30950102
EMDN: W0104080303
EMDN description: STAPHYLOCOCCI SLIDE TESTS
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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Staphaurex Latex Agglutination Test (120 Tests)

STAPHAUREX LATEX AGGLUTATION TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501499
Basic UDI-DI: 50560805StapharexLD
Reference: R30859901
EMDN: W0104080303
EMDN description: STAPHYLOCOCCI SLIDE TESTS
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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STREPTEX ACID EXTRACTION KIT

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501482
Basic UDI-DI: 50560805StreptexAcidExtAE
Reference: R30951301
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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STREPTEX EXTRACTION ENZYME

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501475
Basic UDI-DI: 50560805StreptexEnzymeCU
Reference: R30951001
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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STREPTEX POLYVALENT POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501468
Basic UDI-DI: 50560805StreptexPC63
Reference: R30164601
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX A

STREPTEX LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501406
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950601
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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STREPTEX RAPID

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501390
Basic UDI-DI: 50560805StreptexAcidL5
Reference: R30950555
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details