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Anti-Neutrophil Cytoplasmic Antbodies (anca)

EUDAMED

Class IVD General (EU MDR)

Ref 44911Ref 44851Ref 55566Ref 44850Ref 44852

by Biosystems S.a.

Identity

Device Name
ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA) EUDAMED
Model / Reference
44911 EUDAMED
44851 EUDAMED
55566 EUDAMED
44850 EUDAMED
44852 EUDAMED

Identifiers

Primary DI / UDI-DI
08435287106602 EUDAMED
08435287148510 EUDAMED
08012992555668 EUDAMED
08435287148503 EUDAMED
08435287148527 EUDAMED
Basic UDI-DI
B-08435287106602 EUDAMED
B-08435287148510 EUDAMED
B-08012992555668 EUDAMED
B-08435287148503 EUDAMED
B-08435287148527 EUDAMED
EMDN Code
W0102100499 VASCULITIS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Anti-Neutrophil Cytoplasmic Antbodies (anca) by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Biosystems S.a.
EUDAMED SRN
ES-MF-000000231

Sources (5)

  • EUDAMED 9e84d9c6-64a4-4aa9-8dec-9d4c55fcd2cb 61 fields · synced Sep 17, 2026
  • EUDAMED 8516692c-ea45-4a21-9d1d-59f003810a60 61 fields · synced May 16, 2026
  • EUDAMED e3cc058d-de3f-45be-8a5f-30385a7b7f77 61 fields · synced May 18, 2026
  • EUDAMED 3d108b02-d482-48b1-b870-8529c28b15ac 61 fields · synced May 18, 2026
  • EUDAMED 43cdd426-5d71-49f4-96de-cac449c11395 61 fields · synced May 18, 2026