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517 device results listed.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

ELUENT 80CV

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42510G4
Basic UDI-DI: B-42510G4
Reference: 42510
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

ELUENT 80A

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42508GH
Basic UDI-DI: B-42508GH
Reference: 42508
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

ELUENT 80B

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42509GK
Basic UDI-DI: B-42509GK
Reference: 42509
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

06925912735489

IVD Class ANot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912735489
Basic UDI-DI: 692591270287HZ
Reference: BC9002
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

14562185401353

GX Elution Buffer No. 3 (S)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185401353
Basic UDI-DI: B-14562185401353
Reference: 0023512
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:09

Manufacturer products Authorised representative products Authorised representative actors View details