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BlueWell Deamidated Gliadin IgG ELISA

542502368ECELIAC7J

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680209
Basic UDI-DI: B-05425023680209
Reference: DGLG02-96
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell Deamidated Gliadin IgA ELISA

542502368ECELIAC7J

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680193
Basic UDI-DI: B-05425023680193
Reference: DGLA02-96
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell Transglutaminase IgG ELISA

542502368ECELIAC7J

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680162
Basic UDI-DI: B-05425023680162
Reference: TTG02-96
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell Transglutaminase IgA ELISA

542502368ECELIAC7J

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680148
Basic UDI-DI: B-05425023680148
Reference: TTA02-96
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell Intrinsic Factor IgG

542502368EGASTRITIS3C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680117
Basic UDI-DI: B-05425023680117
Reference: IF01-96
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell Endomysium IgA ELISA

542502368ECELIAC7J

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680063
Basic UDI-DI: B-05425023680063
Reference: ENE02-96
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell ASCA IgA ELISA

542502368ECROHN6V

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680001
Basic UDI-DI: B-05425023680001
Reference: ASCA02-96
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

4SURE Level 2 𝝱-Ketone Control Solution KETONE CONTROL SOLUTION

𝝱 Ketone Control Solution

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815641
Basic UDI-DI: B-05420040815641
Reference: ACS028
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Level 1 KETONE CONTROL SOLUTION

𝝱 Ketone Control Solution

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815634
Basic UDI-DI: B-05420040815634
Reference: ACS027
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Level 3 Blood Glucose Control Solution

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815627
Basic UDI-DI: B-05420040815627
Reference: ACS019
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Level 2 Blood Glucose Control Solution

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815610
Basic UDI-DI: B-05420040815610
Reference: ACS018
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Level 1 Blood Glucose Control Solution

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815603
Basic UDI-DI: B-05420040815603
Reference: ACS017
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE β -KETONE TEST STRIPS

𝝱 Ketone Test Strip

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815597
Basic UDI-DI: B-05420040815597
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE BLOOD GLUCOSE TEST STRIPS

Blood Glucose Test Strip

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815580
Basic UDI-DI: B-05420040815580
Reference: ACS046
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE BLOOD GLUCOSE TEST STRIPS

Blood Glucose Test Strip

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815573
Basic UDI-DI: B-05420040815573
Reference: ACS046
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815559
Basic UDI-DI: B-05420040815559
Reference: GD86
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Smart Duo

Blood Glucose and 𝝱 Ketone Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815542
Basic UDI-DI: B-05420040815542
Reference: GD87
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

Albumin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168017541
Basic UDI-DI: B-05415168017541
Reference: ALTUR-H00/CDC
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:44

Manufacturer products View details

Albumin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168017534
Basic UDI-DI: B-05415168017534
Reference: ALTUR-B00/CDC
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:44

Manufacturer products View details

Haptoglobin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168017527
Basic UDI-DI: B-05415168017527
Reference: HATUR-L00/ATE
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:44

Manufacturer products View details