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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

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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

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Procleix Auto Detect Reagents

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00850032683579
Basic UDI-DI: 0859882007Procleix012ZF
Reference: 9053575
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 06:48

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Oncotype® Sample Prep Kit

Oncotype Sample Prep Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genomic Health Inc.
Manufacturer SRN: US-MF-000018730
UDI-DI: 00852867008053
Basic UDI-DI: 0852867008100407DJ
Reference: 100422
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:35

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OMNIgene Liquefaction Reagent

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000545
Basic UDI-DI: 0627595I0900JF
Reference: OM-LQR-400
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

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PrepIT L2P

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000415
Basic UDI-DI: 0627595H0800HX
Reference: PT-L2P-5
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 01:05

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Dimension Vista V-LYTE Dilution Check

IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Dilution Check

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016257
Basic UDI-DI: 0405686901045UY
Reference: 10445203
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

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Dimension Vista V-LYTE Diluent

IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016240
Basic UDI-DI: 0405686901044UW
Reference: 10445202
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

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Aptiva System Cleaning Solution Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000871
Basic UDI-DI: 0195126000871QG
Reference: AC1003
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 23:03

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PGDx elio diversiPhi

A0840101

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Personal Genome Diagnostics, Inc.
Manufacturer SRN: US-MF-000026862
UDI-DI: 00192721001241
Basic UDI-DI: 0192721U0200400P3
Reference: A0840101
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 23:03

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Working solution eCMA iNOS

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-workingsolutioninosXS
Basic UDI-DI: B-workingsolutioninosXS
Reference: NOX-26.1-VIT
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:31

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Antithrombin III

I0216

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-spimmXQ
Basic UDI-DI: B-spimmXQ
Reference: I0216
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 14:31

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Working solution eCMA MITO

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-eCMAMITO6Y
Basic UDI-DI: B-eCMAMITO6Y
Reference: NOX-22.1-VIT
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:19

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Arbeitslösung eCMA INFLA

Working solution eCMA INFLA

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-eCMAINFLA2A
Basic UDI-DI: B-eCMAINFLA2A
Reference: NOX-24.1-VIT
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:19

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Working solution eCMA ENDO

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-eCMAENDO4H
Basic UDI-DI: B-eCMAENDO4H
Reference: NOX-23.1-VIT
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:19

Manufacturer products View details

Arbeitslösung eCMA PHAGO NOX2

Working solution PHAGO NOX2

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-PHAGONOX2RF
Basic UDI-DI: B-PHAGONOX2RF
Reference: NOX-25.1-VIT
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 09:45

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ESR-Krebs HEPES Buffer VIT

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-ESRKrebsHEPESPufferD5
Basic UDI-DI: B-ESRKrebsHEPESPufferD5
Reference: NOX-21.2-VIT
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 13.07.2026 21:02

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Calibration solution 3-Carboxy-proxyl

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-Calibrationsolution5G
Basic UDI-DI: B-Calibrationsolution5G
Reference: NOX-08.3-VIT
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 13.07.2026 14:13

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CMH

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-CMHCY
Basic UDI-DI: B-CMHCY
Reference: NOX-02.5-VIT
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 13.07.2026 05:08

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ELUENT 80CT

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47301GU
Basic UDI-DI: B-47301GU
Reference: 47301
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details