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CFP88

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257857
Basic UDI-DI: 868499827PCR60XT
Reference: CFP60P100
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 08:11

Manufacturer products View details

SENSITITRE GPALL1F

Sensititre™ GPALL1F

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

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384474356
Basic UDI-DI: 5032384GPALL1FLX
Reference: GPALL1F
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SENSITITRE ARGPF

Sensititre™ ARGPF

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384549580
Basic UDI-DI: 5032384ARGPFQB
Reference: ARGPF
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SENSITITRE FR2STENT

Sensititre FR2STENT

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384565733
Basic UDI-DI: 5032384FR2STENTUK
Reference: FR2STENT
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

PATHOTEC CO (CYTOCHROME OXIDASE)

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838031151
Basic UDI-DI: 8488380Pathotec7W
Reference: R38191
EMDN: W0104080208
EMDN description: SINGLE TESTS (DISCS, STRIPS, DROPPERS...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

BACTICARD STREP

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022494
Basic UDI-DI: 8488380BactiCardStrep3A
Reference: R21112
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Wellcolex Colour Salmonella (200 tests)

IVD Class BNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500508
Basic UDI-DI: 50560805WCSalmonellaNB
Reference: R30858302
EMDN: W0104080301
EMDN description: SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Wellcolex Colour Salmonella (50 tests)

WELLCOLEX COLOUR SALMONELLA

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500485
Basic UDI-DI: 50560805WCSalmonellaNB
Reference: R30858301
EMDN: W0104080301
EMDN description: SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Wellcolex Colour Shigella (50 tests)

WELLCOLEX COLOUR SHIGELLA

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500492
Basic UDI-DI: 50560805WCShigellaNK
Reference: R30858401
EMDN: W0104080301
EMDN description: SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SENSITITRE SEMSE7

Sensititre™ SEMSE7

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384546381
Basic UDI-DI: 5032384SEMSE7RP
Reference: SEMSE7
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

SENSITITRE IRBP11F

Sensititre™ IRBP11F

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384565740
Basic UDI-DI: 5032384IRBP11FKY
Reference: IRBP11F
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

SENSITITRE THAPF

Sensititre™ THAPF

IVD Class BIVDR 2017/746Not intended for EU marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384545971
Basic UDI-DI: 5032384THAPFTQ
Reference: THAPF
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

HB&L CARBAPENEMASE KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Alifax S.r.l.
Manufacturer SRN: IT-MF-000030029
UDI-DI: 08056040149300
Basic UDI-DI: 805604014SI1001.950AG
Reference: SI 1001.950
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Italy
Authorised representative: -
Last updated: 22.09.2026 00:12

Manufacturer products View details

VITEK® 2 AST-P666

IVD generalNot specifiedOn the marketSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026626556
Basic UDI-DI: B-03573026626556
Reference: 543115
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-P665

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026625870
Basic UDI-DI: B-03573026625870
Reference: 543089
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-N407

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026621506
Basic UDI-DI: B-03573026621506
Reference: 542860
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-N406

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026621476
Basic UDI-DI: B-03573026621476
Reference: 542859
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-XN15

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026620295
Basic UDI-DI: B-03573026620295
Reference: 542793
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-XN09

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026618957
Basic UDI-DI: B-03573026618957
Reference: 542573
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

VITEK® 2 AST-N801

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026618919
Basic UDI-DI: B-03573026618919
Reference: 542571
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details