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OMNIgene Liquefaction Reagent

IVD Class AIVDR 2017/746No longer on the marketReagent

Manufacturer: DNA Genotek Inc.
Manufacturer SRN: CA-MF-000003486
UDI-DI: 00627595000552
Basic UDI-DI: 0627595I0900JF
Reference: OM-LQR-1600
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.06.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

UF-CELLSHEATH

IVD Class ANot specifiedOn the market

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562502844
Basic UDI-DI: 4987562UF-CELLSHEATHLK
Reference: BH997335
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 22.06.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

Oncotype® Sample Prep Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genomic Health Inc.
Manufacturer SRN: US-MF-000018730
UDI-DI: 00852867008060
Basic UDI-DI: 0852867008100407DJ
Reference: 100445
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 21.06.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

Procleix Auto Detect Reagents

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00859882007627
Basic UDI-DI: 0859882007Procleix012ZF
Reference: 303345
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: -
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 21.06.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

SALINE DILUENT (NS)

IVD Class ANot specifiedOn the marketNo EU rep

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209389
Basic UDI-DI: 50552732ASALDIL007DT
Reference: SA8396
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 21.06.2026 21:35

Manufacturer products View details

05902643961494

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643961494
Basic UDI-DI: 59026439BBCH103A2
Reference: 1-103-1000
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 21.06.2026 17:14

Manufacturer products View details

05902643961487

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643961487
Basic UDI-DI: 59026439BBCH103A2
Reference: 1-103-0500
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 21.06.2026 17:14

Manufacturer products View details

05902643961463

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643961463
Basic UDI-DI: 59026439BBCH1019W
Reference: 1-101-1000
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 21.06.2026 17:14

Manufacturer products View details

05902643961456

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643961456
Basic UDI-DI: 59026439BBCH1019W
Reference: 1-101-0500
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 21.06.2026 17:14

Manufacturer products View details

04260749390008

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Nephrolyx GmbH
Manufacturer SRN: DE-MF-000024381
UDI-DI: 04260749390008
Basic UDI-DI: B-04260749390008
Reference: PN 001000
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:22

Manufacturer products View details

HbA1C Hemolysis, 1 x 1000 ml

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect marking

Manufacturer: SKALAB s.r.o.
Manufacturer SRN: CZ-MF-000029744
UDI-DI: 08594214080030
Basic UDI-DI: 859421408SKAIVDP4
Reference: 08-118432
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.06.2026 09:23

Manufacturer products View details

HbA1C Hemolysis G8

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect marking

Manufacturer: SKALAB s.r.o.
Manufacturer SRN: CZ-MF-000029744
UDI-DI: 08594214080047
Basic UDI-DI: 859421408SKAIVDP4
Reference: 08-118432 G8
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.06.2026 09:23

Manufacturer products View details

HbA1C Hemolysis, 100 x 1 ml, Z

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect marking

Manufacturer: SKALAB s.r.o.
Manufacturer SRN: CZ-MF-000029744
UDI-DI: 08594214080177
Basic UDI-DI: 859421408SKAIVDP4
Reference: P 012.02.Z
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.06.2026 09:23

Manufacturer products View details

HbA1C Hemolysis, 100 x 1 ml, M

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect marking

Manufacturer: SKALAB s.r.o.
Manufacturer SRN: CZ-MF-000029744
UDI-DI: 08594214080184
Basic UDI-DI: 859421408SKAIVDP4
Reference: P 012.02.M
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.06.2026 09:23

Manufacturer products View details

Cell Preservative Fluid

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411141
Basic UDI-DI: 697309441vails10CB
Reference: 42-1541-00
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Humiss International B.V.
Last updated: 16.06.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

Gyn Cytology Test Kit

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411233
Basic UDI-DI: 697309441TestKit6T
Reference: 90-1350-50
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Humiss International B.V.
Last updated: 16.06.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

Density Reagent

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411240
Basic UDI-DI: 697309441DensityZJ
Reference: 90-1550-00
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Humiss International B.V.
Last updated: 16.06.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

Red Cell Preservative Fluid

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411264
Basic UDI-DI: 697309441RedFluiUC
Reference: C0131JN38
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Humiss International B.V.
Last updated: 16.06.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

Cell Preservative Fluid

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411295
Basic UDI-DI: 697309441vails10CB
Reference: C0111JN18
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Humiss International B.V.
Last updated: 16.06.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

Density Reagent

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesProfessional testingReagentSingle use

Manufacturer: Junocare Medical Devices Ltd
Manufacturer SRN: CN-MF-000030653
UDI-DI: 06973094411370
Basic UDI-DI: 697309441DensityZJ
Reference: C0061JK28
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Humiss International B.V.
Last updated: 16.06.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details