Identity
- Trade Name
- Ocean Dual VIP Ergo EUDAMEDOcean Dual-VIP Ergo Dir.Lock FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Ocean VIP Ergo EUDAMEDOcean Dual-VIP Ergo Dir. Lock FDA UDI
- Model / Reference
- 1604134 EUDAMEDFDA UDI
- Description
- Ocean Dual-VIP Ergo Dir. Lock FDA UDI
Identifiers
- Catalog Number
- 1604134 FDA UDI
- Primary DI / UDI-DI
- 04028698132663 EUDAMEDFDA UDI
- Basic UDI-DI
- 4028698OceanVIPErgoRR 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 Dual VIP 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 | 4028698OceanVIPErgoRR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (2)
- EUDAMED 69488897-f7c1-4182-9df1-02c1f2bad496 61 fields · synced Jul 16, 2026
- FDA UDI f0283b5a-4391-4e36-a712-0ac820638497 35 fields · synced May 30, 2026