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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

CYANElite 290 Washing Solution

CY015-WS

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

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100417
Basic UDI-DI: 54040351CY015-WSXE
Reference: CY015-WS
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

Rinse 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: 05404035100332
Basic UDI-DI: 54040351CY008-WSXQ
Reference: CY005/8-WS-I
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

Washing solution

CY001-WS

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

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100325
Basic UDI-DI: 54040351CY0015L
Reference: CY001-WS
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

CYANElite 290

CY015

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100295
Basic UDI-DI: 54040351CY0155X
Reference: CY015
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:45

Manufacturer products View details

CYANVision

CY014

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100288
Basic UDI-DI: 54040351CY0145V
Reference: CY014
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:45

Manufacturer products View details

TruAna

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763907
Basic UDI-DI: 5065023763TA10001RC
Reference: TA10001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruReno

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763884
Basic UDI-DI: 5065023763TR10001Y9
Reference: TR10001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruLyta

TL100

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763877
Basic UDI-DI: 5065023763TL10001VT
Reference: TL10001
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruOx

TX100

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763815
Basic UDI-DI: 5065023763TX100VT
Reference: TX10001
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruGlyc

TG100

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763785
Basic UDI-DI: 5065023763TG100S4
Reference: TG10001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

TV100

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763396
Basic UDI-DI: 5065023763TV100VD
Reference: TV20001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details