Identity
- Trade Name
- Ocean Ergo EUDAMED
- Device Name
- Ocean Ergo EUDAMED
- Model / Reference
- 1640216 EUDAMED1640215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04028698133196 EUDAMED04028698133189 EUDAMED
- Basic UDI-DI
- 4028698OceanErgoC4 EUDAMED
- EMDN Code
- Y091203 CHAIRS, TOILET AND SHOWER 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
Ocean Ergo 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 | 4028698OceanErgoC4 | Class I | Active |
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Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (2)
- EUDAMED c1e7d24c-70cc-48eb-aab8-b0454ca99fb4 61 fields · synced Jul 17, 2026
- EUDAMED 7bfd73d0-8b13-43e6-bc00-77514f8449aa 61 fields · synced May 17, 2026