Identity
- Trade Name
- Auralis EUDAMEDFDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay system FDA UDI
- Device Name
- AURALIS SEAT CUSHION EUDAMEDFDA UDI
- Model / Reference
- 636C01S EUDAMEDFDA UDI
- Description
- AURALIS SEAT CUSHION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056341675457 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520136VZ EUDAMED
- FDA Product Code
- FNM FDA UDI
- EMDN Code
- V08030101 ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Alternating-pressure bed mattress overlay system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5550 FDA UDI
- Market of Registration
- Austria 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
Yes
FDA UDI
Auralis by Arjohuntleigh 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 | 5060693520136VZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED c9edfa34-4ded-4f49-82e8-0d4f0411ee52 61 fields · synced Jun 8, 2026
- FDA UDI fe1cc9b3-f92a-45d1-9f80-f27a4bfb6f19 33 fields · synced May 29, 2026