Identity
- Device Name
- Beta-Defensin 2 ELISA (960 tests) EUDAMED
- Model / Reference
- IC7210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260154637217 EUDAMED
- Basic UDI-DI
- B-04260154637217 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Beta-Defensin 2 ELISA (960 tests) by ImmuChrom GmbH — 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-04260154637217 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ImmuChrom GmbH
- EUDAMED SRN
- DE-MF-000033427
Sources (2)
- EUDAMED a826adad-76c4-46f3-aa75-44cb8f69f48b 61 fields · synced Jul 9, 2026
- EUDAMED 5f8f0786-a9dc-4d72-b9a8-aecb5c5bd94c 61 fields · synced Jul 9, 2026