Identity
- Trade Name
- HEKA EUDAMED
- Device Name
- HEKA EUDAMED
- Model / Reference
- HEKA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053904842520 EUDAMED
- Basic UDI-DI
- 805390484252DS EUDAMED
- Direct Marketing DI
- 08053904842520 EUDAMED
- EMDN Code
- Y122106 REAR SELF-PROPELLED WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Heka by OFF CARR Srl — 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 | 805390484252DS | Class I | Active |
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Manufacturer
- Manufacturer
- OFF CARR Srl
- EUDAMED SRN
- IT-MF-000024334
Sources (2)
- EUDAMED 8105a1d5-1caf-4113-9de8-b22987f97546 61 fields · synced Jul 11, 2026
- EUDAMED 62230d7e-382b-4ad0-aad4-9c0906c96f88 61 fields · synced Jul 11, 2026