Identity
- Trade Name
- Orca EUDAMED
- Device Name
- Orca EUDAMED
- Model / Reference
- 1573876 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04028698125290 EUDAMED
- Basic UDI-DI
- 4028698OrcaDT EUDAMED
- EMDN Code
- V08050303 BATH LIFTS 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
Orca by Invacare 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 | 4028698OrcaDT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (1)
- EUDAMED a3579901-224f-4fc2-a62f-22704499149f 61 fields · synced Jun 19, 2026