Identity
- Trade Name
- Ocean Ergo XL EUDAMEDOcean 24" XL Dir. Lock FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Ocean Ergo EUDAMEDOcean Ergo XL Dir. Lock FDA UDI
- Model / Reference
- 1643719 EUDAMED1603080 EUDAMEDFDA UDI1640219 EUDAMED
- Description
- Ocean Ergo XL Dir. Lock FDA UDI
Identifiers
- Catalog Number
- 1603080, 1603157 FDA UDI
- Primary DI / UDI-DI
- 04028698133851 EUDAMED04028698132564 EUDAMEDFDA UDI04028698133219 EUDAMED
- 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 XL 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 (4)
- EUDAMED d5e25078-d4e0-4f6e-bd5d-e511ee9b1fbc 61 fields · synced Jul 17, 2026
- EUDAMED 744f49e1-f339-4e44-b333-ced89d2aa2f0 61 fields · synced May 17, 2026
- EUDAMED e61dbd0e-a587-4bee-99d7-f76f6a36ebe8 61 fields · synced May 19, 2026
- FDA UDI a04a3fe4-0afb-4e5f-94ce-6576b38dcf79 36 fields · synced May 30, 2026