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Anti-Adrenal Cortex Antibodies (aaca)

EUDAMED

Class IVD General (EU MDR)

Ref 44574

by Biosystems S.a.

Identity

Device Name
ANTI-ADRENAL CORTEX ANTIBODIES (AACA) EUDAMED
Model / Reference
44574 EUDAMED

Identifiers

Primary DI / UDI-DI
08435287145748 EUDAMED
Basic UDI-DI
B-08435287145748 EUDAMED
EMDN Code
W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

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-Adrenal Cortex Antibodies (aaca) 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 (1)

  • EUDAMED 70c71a41-ba45-4416-924c-7432f10da61d 61 fields · synced Jun 19, 2026