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517 device results listed.

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ELUENT B

IVD Class CIVDR 2017/746Not intended for EU marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 14987486044205
Basic UDI-DI: 4987486BC0109339HF
Reference: 109339
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 29.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT A

IVD Class CIVDR 2017/746Not intended for EU marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 14987486044199
Basic UDI-DI: 4987486BC0109338HD
Reference: 109338
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 29.07.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80CT

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71292HB
Basic UDI-DI: B-71292HB
Reference: 71292
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80CT

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71291H9
Basic UDI-DI: B-71291H9
Reference: 71291
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

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ELUENT 80CV

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71279HK
Basic UDI-DI: B-71279HK
Reference: 71279
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

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ELUENT 80CV

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71278HH
Basic UDI-DI: B-71278HH
Reference: 71278
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

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CONTROL DILUTION SET 80

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71277HF
Basic UDI-DI: B-71277HF
Reference: 71277
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

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HEMOLYSIS WASHING SOLUTION 80H

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71276HD
Basic UDI-DI: B-71276HD
Reference: 71276
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80B

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71275HB
Basic UDI-DI: B-71275HB
Reference: 71275
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80A

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71274H9
Basic UDI-DI: B-71274H9
Reference: 71274
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:30

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL DILUTION SET 80

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71265H8
Basic UDI-DI: B-71265H8
Reference: 71265
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION 80H

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71264H6
Basic UDI-DI: B-71264H6
Reference: 71264
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80B

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71263H4
Basic UDI-DI: B-71263H4
Reference: 71263
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80A

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-71262H2
Basic UDI-DI: B-71262H2
Reference: 71262
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

PDP 50

PYRIDOXAL-5-PHOSPHATE 50

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156001410
Basic UDI-DI: 8592156CCRE0057TE
Reference: 10,003,294
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

XL URINE DIL

XL Urine Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156085601
Basic UDI-DI: 8592156CC0RD055NH
Reference: XSYS0067
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:26

Manufacturer products View details

CatFlux Solutions

CatFlux Solutions for the CatSper Test, CatFlux Control and Test Solution

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

Manufacturer: Truion GmbH
Manufacturer SRN: DE-MF-000034807
UDI-DI: 42700037425116
Basic UDI-DI: 42700037425CATfluxGN
Reference: R1002
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:33

Manufacturer products View details

Procleix Parasite Transport Medium

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007757
Basic UDI-DI: 0859882007Procleix014ZK
Reference: 9051577
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

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Procleix Assay Fluids Kit

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007610
Basic UDI-DI: 0859882007Procleix011ZD
Reference: 303344
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

Procleix SysCheck

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007405
Basic UDI-DI: 0859882007Procleix013ZH
Reference: 301046E
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details