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18.09.2026 16:02

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25 device results listed.

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CELIAC DISEASE SCREENING TEST

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164860015
Basic UDI-DI: 764016486CE2H867
Reference: CE2H88000KIT01IT
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Italy
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Aptiva® Celiac IgA Disease Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040532
Basic UDI-DI: B-08430793040532
Reference: 724120
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Celiac Disease IgG Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040471
Basic UDI-DI: B-08430793040471
Reference: 724100
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Biocard™ Celiac Home

3-028-200

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842928015
Basic UDI-DI: B-06416842928015
Reference: 3-028-200
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:48

Manufacturer products View details

Blocard ™ Celiac Test

Biocard Celiac Test

IVD generalIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842828018
Basic UDI-DI: B-06416842828018
Reference: 3-028-000
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

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 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

GLUTÉNÉRZÉKENYSÉG GYORSTESZT

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164860800
Basic UDI-DI: 764016486CE2H867
Reference: CE2H88B00KIT01HU
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: -
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164861494
Basic UDI-DI: 764016486CE2H867
Reference: CE2H8PR00KIT01IT
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: -
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PRIMA HOME TEST

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164861647
Basic UDI-DI: 764016486CE2H867
Reference: CE2H88000BAG01ED
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: -
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

BlueDiverDot Celiac IgA

BlueDiverDot Celiac

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681626
Basic UDI-DI: 542502368BDDCELIACR5
Reference: ENDADIV-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Celiac IgA

BlueDot Celiac

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680421
Basic UDI-DI: 542502368BDCELIACE4
Reference: ENDA-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Celiac IgG

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680438
Basic UDI-DI: 542502368BDCELIACE4
Reference: ENDG-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDiverDot Celiac IgG

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681633
Basic UDI-DI: 542502368BDDCELIACR5
Reference: ENDGDIV-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

Gliadin-tTransglutaminase IgA Dot

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687062
Basic UDI-DI: 542502368BDCELIACE4
Reference: AD COD
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Gliadin-tTransglutaminase IgG Dot

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687079
Basic UDI-DI: 542502368BDCELIACE4
Reference: AD COGD
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Gliadin- tTransglutaminase IgA Dot for BDI

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687369
Basic UDI-DI: 542502368BDDCELIACR5
Reference: AD CODBD
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details