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05744003280117

Reagent kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280117
Basic UDI-DI: 574400328REAGK8U
Reference: RLA700
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Detergent for Histareader

Rinse solutions for Histareader

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280094
Basic UDI-DI: 574400328RINSECH
Reference: RLA705
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Release 23SEP2013

ver 3.0-0612

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280049
Basic UDI-DI: 574400328SOFTWE5
Reference: v4.0-0613
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Histareader501-1

501

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280025
Basic UDI-DI: 574400328READER8M
Reference: RLA501-1
EMDN: W0201020280
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Release 13AUG2012

ver 3.0-0612

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280032
Basic UDI-DI: 574400328SOFTWE5
Reference: v3.0-0612
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:32

Manufacturer products View details

Histareader501

501

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280018
Basic UDI-DI: 574400328READER8M
Reference: RLA501
EMDN: W0201020280
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:32

Manufacturer products View details

ImmuView® Reader 2.0

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106000076
Basic UDI-DI: 5713106ImmuView_Read23J8
Reference: 213414
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

LiverPRO

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Evido ApS
Manufacturer SRN: DK-MF-000032391
UDI-DI: 05700002258601
Basic UDI-DI: 57000022586LiverPRO38
Reference: /
EMDN: W0201010192
EMDN description: CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 11:48

Manufacturer products View details

05600717621038

H1000

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: LABINLIGHT, LDA
Manufacturer SRN: PT-MF-000034199
UDI-DI: 05600717621038
Basic UDI-DI: 5600717621CARTDRIGE94
Reference: H100050
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Portugal
Authorised representative: -
Last updated: 31.07.2026 11:23

Manufacturer products View details

i-Track 10 Trigger Set

IS-CT100

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420027
Basic UDI-DI: 5425030421024R9
Reference: TD IS-CT100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

i-Track 10 System Liquid

IS-CS100

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420010
Basic UDI-DI: 5425030421017RC
Reference: TD IS-CS100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

i-Track 10 Wash Solution

IS-CW100

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420003
Basic UDI-DI: 5425030421031R6
Reference: TD IS-CW100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software

BlueScan/DrDot

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685013
Basic UDI-DI: 5425023685013VU
Reference: BLUESCAN1 + DR DOT LIC4
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

BlueDiver Instrument

Instrument

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685006
Basic UDI-DI: 5425023685006VX
Reference: BLUEDIVER1
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

Cleaning solution

CY005/8-WS-I - II - III- IV

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100356
Basic UDI-DI: 54040351CY008-WSXQ
Reference: CY008-WS-III
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:58

Manufacturer products View details

AIA-PACK WASH CONCENTRATE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tosoh Europe N.V.
Manufacturer SRN: BE-MF-000000210
UDI-DI: 04562185380033
Basic UDI-DI: 5430000495000020955MW
Reference: 0020955
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:57

Manufacturer products View details

AIA-PACK DILUENT CONCENTRATE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tosoh Europe N.V.
Manufacturer SRN: BE-MF-000000210
UDI-DI: 04562185380026
Basic UDI-DI: 5430000495000020956MY
Reference: 0020956
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:57

Manufacturer products View details

CYANElite 290 Maintenance kit

CY015

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100592
Basic UDI-DI: 54040351CY0155X
Reference: CY015-MIBTR
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

Manufacturer products View details

CYANVision Maintenance kit

CY014

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100400
Basic UDI-DI: 54040351CY0145V
Reference: CY014-MIBTR
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

Manufacturer products View details

Water preservation solution

CY005/8-WS-I - II - III- IV

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100349
Basic UDI-DI: 54040351CY008-WSXQ
Reference: CY008-WS-II
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

Manufacturer products View details