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Standard Air
EUDAMEDFDA UDIClass I (EU MDR)
Ref ESSC1717-1NModel Star CushionsRef ESMC1715-1
Identity
- Trade Name
- Standard Air EUDAMEDStar FDA UDI
- Generic Name
- Air-filled chair cushion FDA UDI
- Device Name
- 17.25 x 15.5 x 3 FDA UDI
- Model / Reference
- Star Cushions EUDAMEDESSC1717-1N EUDAMEDESMC1715-1 EUDAMEDStandard Air Cushion FDA UDI
- Description
- 17.25 x 15.5 x 3 FDA UDI
Identifiers
- Catalog Number
- ESMC1715-1 FDA UDI
- Primary DI / UDI-DI
- 07320451453150 EUDAMED07320450166792 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 (3)
- EUDAMED c9347a6c-1bb4-47f3-9e5f-99db0e6579f0 61 fields · synced Jul 27, 2026
- EUDAMED 2d8ff055-7bf2-4c99-8f12-826ca402c2cf 61 fields · synced May 18, 2026
- FDA UDI d8fe7f48-7671-430e-b1f3-d7fd5990d153 34 fields · synced May 30, 2026