Identity
- Trade Name
- PreventID® CalScreen® EUDAMED
- Device Name
- PreventID® CalScreen® EUDAMED
- Model / Reference
- KST11004GP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598009042 EUDAMED
- Basic UDI-DI
- B-04050598009042 EUDAMED
- EMDN Code
- W0102019009 CALPROTECTIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
PreventID® CalScreen® by Immundiagnostik AG — 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-04050598009042 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED b83745ed-f3d5-49d5-9909-28bfb22e0ce6 61 fields · synced Aug 3, 2026