Identity
- Trade Name
- Pentaflex EUDAMEDFDA UDI
- Generic Name
- Foam-filled bed mattress overlay FDA UDI
- Device Name
- Pentaflex EUDAMEDPentaflex Replacement Mattress, 2 Way, 250kg, Welded FDA UDI
- Model / Reference
- 120PM000/000 EUDAMED250SL000/000W EUDAMEDFDA UDI
- Description
- Pentaflex Replacement Mattress, 2 Way, 250kg, Welded FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056341676164 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520174W9 EUDAMED
- FDA Product Code
- IKY FDA UDI
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
- GMDN Term
- Foam-filled bed mattress overlay FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5150 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
Pentaflex 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 | 5060693520174W9 | 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 834d26e9-65a5-4bf3-9d69-cb9fb80f72d1 61 fields · synced Sep 18, 2026
- FDA UDI 2109491f-49b9-48a9-b32b-773e2d4d75ac 33 fields · synced May 30, 2026