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Alpha Trancell Delux
EUDAMEDFDA UDIClass I (EU MDR)
Ref ATD001DARWModel 636C01S
Identity
- Trade Name
- Alpha Trancell Delux EUDAMEDAlpha Trancell Deluxe FDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay system FDA UDI
- Device Name
- AURALIS SEAT CUSHION EUDAMEDAlpha Trancell Deluxe Mattress Replacement, - 860 x 2040 x 210 mm - Top Cover Dartex - Welded FDA UDI
- Model / Reference
- 636C01S EUDAMEDATD001DARW EUDAMEDFDA UDI
- Description
- Alpha Trancell Deluxe Mattress Replacement, - 860 x 2040 x 210 mm - Top Cover Dartex - Welded FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982789455 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520136VZ EUDAMED
- FDA Product Code
- FNM FDA UDI
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Alpha Trancell Delux 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 7dd1bead-fce4-45fa-bc66-ee5228545af1 61 fields · synced Sep 18, 2026
- FDA UDI ea0e929e-2940-43f2-a41c-c2aa8adc7dae 33 fields · synced May 30, 2026