Identity
- Trade Name
- IDS B2-Glycoprotein I IgM EUDAMED
- Device Name
- IDS B2-Glycoprotein I IgM EUDAMED
- Model / Reference
- IS-AI1602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169694132 EUDAMED
- Basic UDI-DI
- B-05060169694132 EUDAMED
- EMDN Code
- W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
IDS B2-Glycoprotein I IgM by Immunodiagnostic Systems Limited — 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-05060169694132 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (1)
- EUDAMED 5302b8b2-4caf-4431-8abe-3925dfc70e73 61 fields · synced Jul 30, 2026