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25.08.2026 11:44

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Active filter:Manufacturer SRN:JP-MF-000008516

20 device results listed.

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PATHFAST TB LAM Ag

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301162
Basic UDI-DI: 4987595PF1231KXJ
Reference: 30116
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300820
Basic UDI-DI: 4987595PATHFASTSC
Reference: 300820
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

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PATHFAST SAMPLE DILUENT 3

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300035
Basic UDI-DI: 4987595PF03D6K
Reference: 30003
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

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PATHFAST SAMPLE DILUENT 2

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300028
Basic UDI-DI: 4987595PF02D6G
Reference: 30002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST SAMPLE DILUENT 1

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300011
Basic UDI-DI: 4987595PF01D6D
Reference: 30001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST B･R･A･H･M･S PCT Control

PATHFAST B·R·A·H·M·S PCT Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595302107
Basic UDI-DI: 4987595PF0221CWJ
Reference: 30210
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7022C · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST Presepsin Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595302008
Basic UDI-DI: 4987595PF0201CW8
Reference: 30200
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7020C · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST hsCRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301711
Basic UDI-DI: 4987595PF1071KXQ
Reference: 30171
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7007 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST NTproBNP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301612
Basic UDI-DI: 4987595PF1061KXK
Reference: 30161
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7006 · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST D-Dimer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301513
Basic UDI-DI: 4987595PF1051KXE
Reference: 30151
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7005 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST CK-MB

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301315
Basic UDI-DI: 4987595PF1031KX4
Reference: 30131
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7003 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST Presepsin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301254
Basic UDI-DI: 4987595PF1201KX3
Reference: 30125
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7020 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST Myo

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301216
Basic UDI-DI: 4987595PF1021KWX
Reference: 30121
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7002 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST hs-cTnI

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301179
Basic UDI-DI: 4987595PF1241KXP
Reference: 30117
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7024 · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST B·R·A·H·M·S PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301155
Basic UDI-DI: 4987595PF1221KXD
Reference: 30115
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7022 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST cTnI

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301117
Basic UDI-DI: 4987595PF1011KWS
Reference: 30111
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7001 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST TB LAM Ag Control

PATHFAST TB LAM Ag Conttrol

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

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301940
Basic UDI-DI: 4987595PF0231CWP
Reference: 30194
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 02.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300929
Basic UDI-DI: 4987595PATHFASTSC
Reference: 300929
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 22.06.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST TIP

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300936
Basic UDI-DI: 4987595PATHFASTSC
Reference: 300936
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 22.06.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST WASTE BOX

IVD Class ANot specifiedOn the market

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595300950
Basic UDI-DI: 4987595PATHFASTSC
Reference: 300950
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 22.06.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details