Identity
- Device Name
- Deterioration Index EUDAMED
- Model / Reference
- None EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860475000376 EUDAMED
- Basic UDI-DI
- 08604750003DIXH EUDAMED
- Direct Marketing DI
- 00860475000376 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Deterioration Index by Epic Systems Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08604750003DIXH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Epic Systems Corporation
- EUDAMED SRN
- US-MF-000002900
- Authorised Representative
- Epic Den Bosch B.V. NL-AR-000001967
Sources (1)
- EUDAMED f876c374-b654-44b7-9cf1-20a23b194e30 61 fields · synced Jun 19, 2026