Identity
- Device Name
- CERULOPLASMIN EUDAMEDCERULOPLASMIN CALIBRATOR EUDAMED
- Model / Reference
- 13340 EUDAMED22340 EUDAMED31340 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287112016 EUDAMED08435287112023 EUDAMED08435287111996 EUDAMED
- Basic UDI-DI
- B-08435287112016 EUDAMEDB-08435287112023 EUDAMEDB-08435287111996 EUDAMED
- EMDN Code
- W0102010301 CERULOPLASMIN EUDAMEDW0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Ceruloplasmin 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-08435287112016 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED 5422d9d1-1bd7-4af2-80d4-2fa9a5f664a6 61 fields · synced Jul 17, 2026
- EUDAMED 6fe936eb-8d26-40e5-86b7-7dcf6882d9e5 61 fields · synced May 17, 2026
- EUDAMED dd7e8e5a-2104-45de-8a5c-05c478f20fc6 61 fields · synced May 18, 2026