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Aea Positive Control
EUDAMEDClass IVD General (EU MDR)
Ref 44894Ref 44893Ref 44549
Identity
- Device Name
- AEA POSITIVE CONTROL EUDAMED
- Model / Reference
- 44894 EUDAMED44893 EUDAMED44549 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08012992503720 EUDAMED08435287106183 EUDAMED08435287145496 EUDAMED
- Basic UDI-DI
- B-08012992503720 EUDAMEDB-08435287106183 EUDAMEDB-08435287145496 EUDAMED
- EMDN Code
- W0102152003 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 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-08012992503720 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED e3e3b61e-6bc5-4dae-9563-78a1730c511c 61 fields · synced Jul 26, 2026
- EUDAMED cc7e0f25-e366-4a37-9401-00bc8713e3fa 61 fields · synced May 17, 2026
- EUDAMED 71aef95a-7093-4bd6-aeff-798594d9b961 61 fields · synced May 18, 2026