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EliA Calprotectin Negative Control 250
EUDAMEDClass B (EU MDR)
Ref 83-1085-01
by Phadia AB
Identity
- Trade Name
- EliA Calprotectin Negative Control 250 EUDAMED
- Device Name
- EliA Calprotectin 2 EUDAMED
- Model / Reference
- 83-1085-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066013367 EUDAMED
- Basic UDI-DI
- 7333066BUDI0116M2 EUDAMED
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Sweden 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
EliA Calprotectin Negative Control 250 by Phadia AB — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0116M2 | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED c5860ab9-aadc-402a-81cb-7fb50c3d4f7f 61 fields · synced Jul 18, 2026