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02.08.2026 22:01

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16 device results listed.

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ASCA Screen IgA+IgG Dot for BDI

BlueDiverDot ASCA

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687338
Basic UDI-DI: 542502368BDDCROHNHE
Reference: AD ASCASDBD
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

Lysozyme

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276226
Basic UDI-DI: B-86060313276226
Reference: C1815LYS
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Zonulin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276080
Basic UDI-DI: B-86060313276080
Reference: C1826ZON
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

β-Defensin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275922
Basic UDI-DI: B-86060313275922
Reference: C1818DEF
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

EDN

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275236
Basic UDI-DI: B-86060313275236
Reference: C1819EDN
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

08435287148725

ASCA-IgG/IgA (ASCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148725
Basic UDI-DI: B-08435287148725
Reference: 44872
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

07090028592505

CAL250

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Calpro AS
Manufacturer SRN: NO-MF-000036194
UDI-DI: 07090028592505
Basic UDI-DI: B-07090028592505
Reference: CAL250
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Norway
Authorised representative: -
Last updated: 07.07.2026 02:57

Manufacturer products View details

07090028592406

CAL240

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Calpro AS
Manufacturer SRN: NO-MF-000036194
UDI-DI: 07090028592406
Basic UDI-DI: B-07090028592406
Reference: CAL230
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Norway
Authorised representative: -
Last updated: 07.07.2026 02:57

Manufacturer products View details

07090028592307

CAL230

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Calpro AS
Manufacturer SRN: NO-MF-000036194
UDI-DI: 07090028592307
Basic UDI-DI: B-07090028592307
Reference: CAL230
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Norway
Authorised representative: -
Last updated: 07.07.2026 02:57

Manufacturer products View details

Sharay Anti-Saccharomyces cerevisiae IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070767785
Basic UDI-DI: B-06975070767785
Reference: 18199002
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Saccharomyces cerevisiae IgA (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070767778
Basic UDI-DI: B-06975070767778
Reference: 18163002
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Intestinal Goblet Cell IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070767747
Basic UDI-DI: B-06975070767747
Reference: 18161002
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Intestinal Goblet Cell IgA (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070767730
Basic UDI-DI: B-06975070767730
Reference: 18162002
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:46

Manufacturer products Authorised representative products Authorised representative actors View details

EliA ASCA IgG Well

EliA ASCA IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015705
Basic UDI-DI: 7333066BUDI0117M4
Reference: 14-5635-01
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

EliA ASCA IgA Well

EliA ASCA IgA

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015699
Basic UDI-DI: 7333066BUDI0028M4
Reference: 14-5633-01
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

DIASpot Neptune ASCA IgG + IgA

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023688168
Basic UDI-DI: 542502368BDDCROHNHE
Reference: KAPDTASCCN
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details