Identity
- Trade Name
- StabilAir EUDAMEDStar FDA UDI
- Generic Name
- Air-filled chair cushion FDA UDI
- Device Name
- 11.75 x 13.5 x 3 FDA UDI
- Model / Reference
- Star Cushions EUDAMEDESSA31113-1 EUDAMEDStabil-Air Cushion FDA UDI
- Description
- 11.75 x 13.5 x 3 FDA UDI
Identifiers
- Catalog Number
- ESSA31113-1 FDA UDI
- Primary DI / UDI-DI
- 07320450168116 EUDAMEDFDA UDI
- Basic UDI-DI
- 73204510444H EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- Y122406 BELTS, SEATS AND ARMRESTS FOR WHEELCHAIRS EUDAMED
- GMDN Term
- Air-filled chair cushion FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
StabilAir by Etac Supply Center Ab — 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 | 73204510444H | 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
- Etac Supply Center AB
- EUDAMED SRN
- SE-MF-000001230
Sources (2)
- EUDAMED 7bc3a9c0-4461-4ba2-b2f0-772c141ff641 61 fields · synced Jul 10, 2026
- FDA UDI 48974c8b-f289-4373-a915-5ea1584badfa 34 fields · synced May 30, 2026