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280 device results listed.

Page 13 / 14

Anti-ovarian antibody IgG (AOA-IgG) Dectection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522640975
Basic UDI-DI: B-06970522640975
Reference: DB0601
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-ovarian antibody IgM (AOA-IgM) Dectection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522640692
Basic UDI-DI: B-06970522640692
Reference: DB0701
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-trophoblast cell membrane antibody(TA-Ab) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502569
Basic UDI-DI: B-06942028502569
Reference: DB2201
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Human Chorionic Gonadotropin antibody (HCG-Ab) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501968
Basic UDI-DI: B-06942028501968
Reference: DB1401
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-zona pellucida antibody IgM(ZP-IgM) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501920
Basic UDI-DI: B-06942028501920
Reference: DB1301
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-zona pellucida antibody IgG(ZP-IgG) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501883
Basic UDI-DI: B-06942028501883
Reference: DB1201
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Biermer Atrophic Gastritis Dot

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687048
Basic UDI-DI: 542502368BDGASTRITISLY
Reference: AD BAGD
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Biermer Atrophic Gastritis Dot for BDI

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687345
Basic UDI-DI: 542502368BDDGASTRITISC2
Reference: AD BAGDBD
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

DIASpot Gastritis IgG

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023688076
Basic UDI-DI: 542502368BDGASTRITISLY
Reference: KAPDTIFPCA
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

DIASpot Neptune Gastritis IgG

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023688229
Basic UDI-DI: 542502368BDDGASTRITISC2
Reference: KAPDTIFPCAN
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

RiaRSR™ MuSK Ab

-

IVD generalNot specifiedOn the market

Manufacturer: RSR Limited
Manufacturer SRN: GB-MF-000025180
UDI-DI: 05056509600284
Basic UDI-DI: B-05056509600284
Reference: MSK/25
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 19.06.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

ElisaRSR™ 21-OH Ab

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IVD generalNot specifiedOn the market

Manufacturer: RSR Limited
Manufacturer SRN: GB-MF-000025180
UDI-DI: 05056509600031
Basic UDI-DI: B-05056509600031
Reference: 21E/96/R
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 19.06.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

ElisaRSR™ 21-OH Ab

-

IVD generalNot specifiedOn the market

Manufacturer: RSR Limited
Manufacturer SRN: GB-MF-000025180
UDI-DI: 05056509600024
Basic UDI-DI: B-05056509600024
Reference: 21E/96
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 19.06.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

LISA-TRACKER TNFalpha

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IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672000769
Basic UDI-DI: B-03532672000769
Reference: LTT 004-96
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 17.06.2026 02:03

Manufacturer products View details

Anti-PLA2R CLIA Assay Kit

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IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222762
Basic UDI-DI: B-06975424222762
Reference: CL30282E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-PR3 CLIA Assay Kit

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IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222748
Basic UDI-DI: B-06975424222748
Reference: CL30102E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Myeloperoxidase CLIA Assay Kit

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IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222731
Basic UDI-DI: B-06975424222731
Reference: CL30112E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

GADA CLIA Assay Kit

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IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222625
Basic UDI-DI: B-06975424222625
Reference: CL30152E
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Evo Autoimmune SPA

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IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 48058945154487
Basic UDI-DI: 8058945153AU3020AIHM
Reference: 3AU3020 AMA
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 04:22

Manufacturer products View details

Evo Autoimmune SPA

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IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 48058945154494
Basic UDI-DI: 8058945153AU3020AIHM
Reference: 3AU3020 b2-GPI
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 04:22

Manufacturer products View details