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AESKULISA® dsDNA-G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500647
Basic UDI-DI: B-04250289500647
Reference: 3142
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 22.07.2026 00:03

Manufacturer products View details

Antinuclear Antibody (ANA) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OANA-402D7
Basic UDI-DI: B-OANA-402D7
Reference: OANA-402
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Anti-TPO Ab

IVDR_67_LLB_DUB-C_B_KIT_Anti-TPO Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962153
Basic UDI-DI: 0405686901370VE
Reference: 10381649
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII)

IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608570
Basic UDI-DI: 0405686902269VX
Reference: 11206075
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Anti-Thyroid Peroxidase II (aTPOII)

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608761
Basic UDI-DI: 0405686902269VX
Reference: 11206077
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII)

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414608747
Basic UDI-DI: 0405686902269VX
Reference: 11206074
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

AESKULISA® ENA-6 Stripes

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289503495
Basic UDI-DI: B-04250289503495
Reference: 3120
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:38

Manufacturer products View details

AESKULISA® ANA Hep-2 quantitative

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289503426
Basic UDI-DI: B-04250289503426
Reference: 3119
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:38

Manufacturer products View details

AESKULISA® PM-Scl

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500593
Basic UDI-DI: B-04250289500593
Reference: 3117
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:38

Manufacturer products View details

AESKULISA® DANA-Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500586
Basic UDI-DI: B-04250289500586
Reference: 3116
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:38

Manufacturer products View details

AESKULISA® ANA HEp-2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500579
Basic UDI-DI: B-04250289500579
Reference: 3115
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:38

Manufacturer products View details

AESKULISA® Rib-P

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500562
Basic UDI-DI: B-04250289500562
Reference: 3114
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:37

Manufacturer products View details

AESKULISA® Jo-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500555
Basic UDI-DI: B-04250289500555
Reference: 3113
EMDN: W0102100108
EMDN description: JO-1
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:37

Manufacturer products View details

AESKULISA® Cenp-B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500548
Basic UDI-DI: B-04250289500548
Reference: 3112
EMDN: W0102100115
EMDN description: ANTI-CENTROMERE ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:37

Manufacturer products View details

AESKULISA® Scl-70

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500531
Basic UDI-DI: B-04250289500531
Reference: 3111
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:37

Manufacturer products View details

D-R1341528

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1341528
Basic UDI-DI: B-R1341528
Reference: R13415
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 20.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-tTG IgG

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76488GP
Basic UDI-DI: B-DC76488GP
Reference: DC76488
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-tTG IgG

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76487GM
Basic UDI-DI: B-DC76487GM
Reference: DC76487
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-β2-Glycoprotein I IgM

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76449GD
Basic UDI-DI: B-DC76449GD
Reference: DC76449
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-A5093

INDICAID™ Antisperm Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5093
Basic UDI-DI: B-A5093
Reference: INDICAID™ Antisperm Antibody Test
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details