Identity
- Trade Name
- Standard Air EUDAMEDStar FDA UDI
- Generic Name
- Air-filled chair cushion FDA UDI
- Device Name
- 15.5 x 17.25 x 2 2V LTR FDA UDI
- Model / Reference
- Star Cushions EUDAMEDESSCS1517-2 EUDAMEDStandard Air Cushion FDA UDI
- Description
- 15.5 x 17.25 x 2 2V LTR FDA UDI
Identifiers
- Catalog Number
- ESSCS1517-2 FDA UDI
- Primary DI / UDI-DI
- 07320450171307 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
Standard Air 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 |
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Manufacturer
- Manufacturer
- Etac Supply Center AB
- EUDAMED SRN
- SE-MF-000001230
Sources (2)
- EUDAMED b643696b-6e4a-42cf-9a74-19e5ae37036e 61 fields · synced Jun 19, 2026
- FDA UDI 92ff1053-03d9-42c0-aa18-0950ae044a59 34 fields · synced May 30, 2026