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Autoantibodies-Rl/Rk/Rs (aa-Rl +2 more)

EUDAMED

Class IVD General (EU MDR)

Ref 44648Ref 44558Ref 44639Ref 50052Ref 44570

by Biosystems S.a.

Identity

Device Name
AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS) EUDAMED
Model / Reference
44648 EUDAMED
44558 EUDAMED
44639 EUDAMED
50052 EUDAMED
44570 EUDAMED

Identifiers

Primary DI / UDI-DI
08435287146486 EUDAMED
08435287145588 EUDAMED
08435287146394 EUDAMED
08012992500521 EUDAMED
08435287144703 EUDAMED
Basic UDI-DI
B-08435287146486 EUDAMED
B-08435287145588 EUDAMED
B-08435287146394 EUDAMED
B-08012992500521 EUDAMED
B-08435287144703 EUDAMED
EMDN Code
W0102100799 AUTOIMMUNE HEPATITIS - OTHER EUDAMED
Models / Variants
aa-Rl EUDAMED
Rk EUDAMED
Rs EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMEDEUDAMED

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

Autoantibodies-Rl/Rk/Rs (aa-Rl +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

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Manufacturer

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

Sources (5)

  • EUDAMED de6ed9c3-4d6d-4239-a59a-f052bd16bc9e 61 fields · synced Aug 2, 2026
  • EUDAMED 1ced56c1-1611-4415-9579-3dc5a3f736f9 61 fields · synced May 17, 2026
  • EUDAMED 69ee719c-2892-4ebd-a0f2-c78e2ea88474 61 fields · synced May 18, 2026
  • EUDAMED 6d4d0d48-98ac-48ed-843c-acd141227c4f 61 fields · synced May 18, 2026
  • EUDAMED 1e47ed8e-7e6e-4166-8fe5-6c944ddb0a0b 61 fields · synced May 18, 2026