Identity
- Trade Name
- SO-ZEKA 1065/E EUDAMED
- Device Name
- Kardiographieliege EUDAMED
- Model / Reference
- SO-ZEKA 1065/E EUDAMED68 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251816802043 EUDAMED
- Basic UDI-DI
- 42518168020497 EUDAMED
- Direct Marketing DI
- 04251816802043 EUDAMED
- EMDN Code
- V080699 MEDICAL BEDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
So-Zeka 1065/E by AGA Sanitätsartikel GmbH — Class I — 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 | 42518168020497 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AGA Sanitätsartikel GmbH
- EUDAMED SRN
- DE-MF-000005876
Sources (1)
- EUDAMED 57b30c36-d6a5-400b-9167-f99e99ffcaaa 61 fields · synced Oct 6, 2026