Identity
- Trade Name
- Auditbase EUDAMED
- Device Name
- Auditbase EUDAMED
- Model / Reference
- 2003 Auditbase EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05711781002064 EUDAMED
- Basic UDI-DI
- 05711781DHF2003-12Z EUDAMED
- Direct Marketing DI
- 05711781002064 EUDAMED
- EMDN Code
- Z12149092 VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark 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
Auditbase by Auditdata A/S — 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 | 05711781DHF2003-12Z | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Auditdata A/S
- EUDAMED SRN
- DK-MF-000011415
Sources (1)
- EUDAMED cc12e24a-a135-4a8b-a67b-a072e34771ff 61 fields · synced Jun 18, 2026