← Back to catalogue
EliA Calprotectin Positive Control 2500/5000
EUDAMEDClass B (EU MDR)
Ref 83-1084-01
by Phadia AB
Identity
- Trade Name
- EliA Calprotectin Positive Control 2500/5000 EUDAMED
- Device Name
- EliA Calprotectin 2 EUDAMED
- Model / Reference
- 83-1084-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066013404 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 Positive Control 2500/5000 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED 6a3be9c5-78b2-42a4-b9f0-8234f9e4b526 61 fields · synced Jun 18, 2026