Identity
- Trade Name
- OneWayGlide EUDAMEDImmedia FDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- OneWayGlide EUDAMED
- Model / Reference
- Positioning Sitting EUDAMEDIM45/8 EUDAMEDOneWayGlide Velour FDA UDI
Identifiers
- Catalog Number
- IM45/8 FDA UDI
- Primary DI / UDI-DI
- 05708012317561 EUDAMEDFDA UDI
- Basic UDI-DI
- 57080122004LX EUDAMED
- FDA Product Code
- IKX FDA UDI
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
- GMDN Term
- Wheelchair seat cushion FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Denmark 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
OneWayGlide by Etac Immedia A/S — 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 | 57080122004LX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (2)
- EUDAMED f1648793-99ba-4bec-b459-0f3be5f71f34 61 fields · synced Jul 29, 2026
- FDA UDI e2869307-758a-463e-8be0-d0d5d1bddcc6 33 fields · synced May 30, 2026