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ANTI-beta-2-GLYCOPROTEIN 1 IgG/IgM (betaGP1)
EUDAMEDClass IVD General (EU MDR)
Ref 44868
Identity
- Device Name
- ANTI-beta-2-GLYCOPROTEIN 1 IgG/IgM (betaGP1) EUDAMED
- Model / Reference
- 44868 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287148688 EUDAMED
- Basic UDI-DI
- B-08435287148688 EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - 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-beta-2-GLYCOPROTEIN 1 IgG/IgM (betaGP1) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08435287148688 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (1)
- EUDAMED be58eb55-1127-45be-b618-0a26f4572c51 61 fields · synced Jun 18, 2026