Identity
- Device Name
- Regulated Decision Support Framework EUDAMED
- Model / Reference
- None EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860475000338 EUDAMED
- Basic UDI-DI
- B-00860475000338 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Regulated Decision Support Framework by Epic Systems Corporation — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00860475000338 | Class I | 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 81cecb68-2f5d-4073-b152-0f8908e05f1a 61 fields · synced Jul 16, 2026