Identity
- Trade Name
- Ocean Ergo EUDAMEDOcean Ergo Dir. Lock FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Ocean Ergo EUDAMEDOcean Ergo Dir. Lock FDA UDI
- Model / Reference
- 1603032 EUDAMEDFDA UDI
- Description
- Ocean Ergo Dir. Lock FDA UDI
Identifiers
- Catalog Number
- 1603032, 1601987 FDA UDI
- Primary DI / UDI-DI
- 04028698132540 EUDAMEDFDA UDI
- Basic UDI-DI
- 4028698OceanErgoC4 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y091203 CHAIRS, TOILET AND SHOWER EUDAMED
- GMDN Term
- Shower seat, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ocean Ergo by Invacare GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4028698OceanErgoC4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (2)
- EUDAMED c3c17420-0d77-4f70-bf9c-291a74abcdb0 61 fields · synced Jun 1, 2026
- FDA UDI 23aaf585-c8a5-4f81-92de-68945629e2af 35 fields · synced May 30, 2026