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Autoantibodies Msl/Msk/Mss (aa-Msl +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref 44826Ref 50061
Identity
- Device Name
- AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS) EUDAMED
- Model / Reference
- 44826 EUDAMED50061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287148268 EUDAMED08012992500613 EUDAMED
- Basic UDI-DI
- B-08435287148268 EUDAMEDB-08012992500613 EUDAMED
- EMDN Code
- W0102100799 AUTOIMMUNE HEPATITIS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 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-08435287148268 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 4aab9922-3493-4e85-96ce-c2cc7e6adcbb 61 fields · synced Jul 27, 2026
- EUDAMED c66fdbc0-b5ff-4e03-a638-2af599f462aa 61 fields · synced May 11, 2026