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AEA IgG POSITIVE CONTROL
EUDAMEDClass IVD General (EU MDR)
Ref 12012273Ref 44732
Identity
- Device Name
- AEA IgG POSITIVE CONTROL EUDAMED
- Model / Reference
- 12012273 EUDAMED44732 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610522158263 EUDAMED08435287110593 EUDAMED
- Basic UDI-DI
- B-03610522158263 EUDAMEDB-08435287110593 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMEDW0102152003 SPECIFIC PROTEIN CONTROLS 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
AEA IgG POSITIVE CONTROL 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-03610522158263 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED a01fc011-447a-43e9-9f62-0fb69c117139 61 fields · synced Jul 31, 2026
- EUDAMED e010210e-e15a-4b05-a4f7-1e1a3de89d59 61 fields · synced May 18, 2026