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04099466105417

Serazym® Anti-Cardiolipin-ß2-GP-1 IgG/IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466105417
Basic UDI-DI: B-04099466105417
Reference: E-054
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

ANA Hep-2

FA2500A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ZEUS Scientific
Manufacturer SRN: US-MF-000026845
UDI-DI: 00845533001892
Basic UDI-DI: B-00845533001892
Reference: FA2500A
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIATPO102001

NovaLisa® Anti-TPO

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIATPO102001
Basic UDI-DI: B-+ENTIATPO102001
Reference: ATPO1020
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTIATG10100A

NovaLisa® Anti-TG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIATG10100A
Basic UDI-DI: B-+ENTIATG10100A
Reference: ATG1010
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

CHORUS MPO

CHORUSMPO

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891324599
Basic UDI-DI: 803389132CHORUSMPO200B4
Reference: 86120
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:48

Manufacturer products View details

BioCLIA Autoimmune Reagent Kit, Mi-2

BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416836
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02274
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiverDot ANA + DFS-70 IgG

BlueDiver Dot

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681695
Basic UDI-DI: 542502368BDDANAYE
Reference: RLH12DIV-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 09:59

Manufacturer products View details

ADVIA Centaur Neurofilament Light Chain (NfL)

IVDR_67_TTN_DUB-C_C_REAG_KIT_sNfL 100T Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414635439
Basic UDI-DI: 0405686902255VL
Reference: 11553990
EMDN: W0102100299
EMDN description: NEURO-AUTO-IMMUNE DISEASE - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM 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: 00630414608754
Basic UDI-DI: 0405686902269VX
Reference: 11206076
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Anti-Thyroglobulin II (aTgII)

IVDR_67_LLB_DUB-C_B_KIT_aTgII

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414245317
Basic UDI-DI: 0405686901371VG
Reference: 11201759
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-tTG IgG Anti-tissue Transglutaminase IgG Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-anti-tTG706-AEYS
Basic UDI-DI: B-anti-tTG706-AEYS
Reference: "anti-tTG706-AE10Y, anti-tTG706-AE10N, anti-tTG706-AE20Y, anti-tTG706-AE20N
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-anti-dsDNA706-AEST
Basic UDI-DI: B-anti-dsDNA706-AEST
Reference: anti-dsDNA706-AE10Y, anti-dsDNA706-AE10N, anti-dsDNA706-AE20Y, anti-dsDNA706-AE20N
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-R994496T

N/A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-R994496T
Basic UDI-DI: B-R994496T
Reference: R99449
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 05:25

Manufacturer products View details

D-R01210YQ

N/A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-R01210YQ
Basic UDI-DI: B-R01210YQ
Reference: R01210
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 05:23

Manufacturer products View details

INNODX TRAb CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TRAb-04100Y3
Basic UDI-DI: B-KR-TRAb-04100Y3
Reference: KR-TRAb-04100
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TRAb CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TRAb-0250LT
Basic UDI-DI: B-KR-TRAb-0250LT
Reference: KR-TRAb-0250
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TRAb CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TRAb-02200XS
Basic UDI-DI: B-KR-TRAb-02200XS
Reference: KR-TRAb-02200
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TRAb CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TRAb-01100XE
Basic UDI-DI: B-KR-TRAb-01100XE
Reference: KR-TRAb-01100
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TPO-Ab CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TPOAb-01100CWB
Basic UDI-DI: B-KR-TPOAb-01100CWB
Reference: KR-TPO Ab-01100C
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX TG-Ab CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-TG-Ab-01100CPL
Basic UDI-DI: B-KR-TG-Ab-01100CPL
Reference: KR-TG-Ab-01100C
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details