Autoantibodies Msl/Msk/Mss (aa-Msl +2 more)

EUDAMED

Class IVD General (EU MDR)

Ref 44827

by Biosystems S.a.

Identity

Device Name: AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS) EUDAMED
Model / Reference: 44827 EUDAMED

Identifiers

Primary DI / UDI-DI: 08435287148275 EUDAMED
Basic UDI-DI: B-08435287148275 EUDAMED
EMDN Code: W0102100799 AUTOIMMUNE HEPATITIS - OTHER EUDAMED
Models / Variants: aa-Msl EUDAMED
Msk EUDAMED
Mss EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Autoantibodies Msl/Msk/Mss (aa-Msl +2 more) by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — 3 models — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-08435287148275	Class IVD General	Active

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Manufacturer

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

Sources (1)

EUDAMED daae5c47-25a8-4424-b253-463b093036fa 61 fields · synced Jun 19, 2026