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Pancreatic elastase ELISA (96 tests)
EUDAMEDClass IVD General (EU MDR)
Ref IC7400
Identity
- Device Name
- Pancreatic elastase ELISA (96 tests) EUDAMED
- Model / Reference
- IC7400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260154637408 EUDAMED
- Basic UDI-DI
- B-04260154637408 EUDAMED
- EMDN Code
- W0101060303 PANCREAS-ELASTASE 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
Pancreatic elastase ELISA (96 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-04260154637408 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ImmuChrom GmbH
- EUDAMED SRN
- DE-MF-000033427
Sources (2)
- EUDAMED 818ebfb4-c278-49e2-9346-6e9ce0fdd00a 61 fields · synced Jul 13, 2026
- EUDAMED b66ebb8f-88da-4f49-a811-2ccfc9034c53 61 fields · synced Jul 13, 2026