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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

PVT5 (Precision and Accuracy Check)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472055PX
Basic UDI-DI: B-472055PX
Reference: 472055
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

PVT2 (Buffer Blank And Cuvette Dryness Test)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442831PQ
Basic UDI-DI: B-442831PQ
Reference: 442831
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

PVT3 (Combined Carryover Test)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442830PN
Basic UDI-DI: B-442830PN
Reference: 442830
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Z-Hb Confirm Reagent Kit (HPLC)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ZOVEC diagnostics GmbH
Manufacturer SRN: DE-MF-000035393
UDI-DI: 42625753901396
Basic UDI-DI: B-42625753901396
Reference: Z-RHB
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:42

Manufacturer products View details

Daily Cleaners kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ZOVEC diagnostics GmbH
Manufacturer SRN: DE-MF-000035393
UDI-DI: 42625753900238
Basic UDI-DI: B-42625753900238
Reference: ZA-EC1
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:42

Manufacturer products View details

CONTROL DILUTION SET 80

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42512G8
Basic UDI-DI: B-42512G8
Reference: 42512
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 19:17

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-42511G6
Basic UDI-DI: B-42511G6
Reference: 42511
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 19:17

Manufacturer products Authorised representative products Authorised representative actors View details