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08012992555651

ANTI-SKIN ANTIBODIES (ASA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992555651
Basic UDI-DI: B-08012992555651
Reference: 55565
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:46

Manufacturer products View details

08012992500651

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500651
Basic UDI-DI: B-08012992500651
Reference: 50065
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

Manufacturer products View details

08012992500620

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500620
Basic UDI-DI: B-08012992500620
Reference: 50062
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500613

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500613
Basic UDI-DI: B-08012992500613
Reference: 50061
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500644

ANTI-nDNA ANTIBODIES (nDNA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500644
Basic UDI-DI: B-08012992500644
Reference: 50064
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500637

ANTI-nDNA ANTIBODIES (nDNA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500637
Basic UDI-DI: B-08012992500637
Reference: 50063
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500606

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500606
Basic UDI-DI: B-08012992500606
Reference: 50060
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500590

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500590
Basic UDI-DI: B-08012992500590
Reference: 50059
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500583

ANTI-ENDOMYSIUM ANTIBODIES (AEA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500583
Basic UDI-DI: B-08012992500583
Reference: 50058
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500576

ANTI-ENDOMYSIUM ANTIBODIES (AEA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500576
Basic UDI-DI: B-08012992500576
Reference: 50057
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500569

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500569
Basic UDI-DI: B-08012992500569
Reference: 50056
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500552

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500552
Basic UDI-DI: B-08012992500552
Reference: 50055
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500545

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500545
Basic UDI-DI: B-08012992500545
Reference: 50054
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500538

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500538
Basic UDI-DI: B-08012992500538
Reference: 50053
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500521

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500521
Basic UDI-DI: B-08012992500521
Reference: 50052
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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-U1-RNP (CLIA)

50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460550
Basic UDI-DI: B-06980070460550
Reference: 14000877
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay APS IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460062
Basic UDI-DI: B-06980070460062
Reference: 14000781
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details