Identity
- Trade Name
- Simulflex EUDAMEDFDA UDI
- Generic Name
- Foam-filled bed mattress overlay FDA UDI
- Device Name
- Pentaflex EUDAMEDSimulflex Replacement Mattress, 4 Way, 120kg, FDA UDI
- Model / Reference
- 120PM000/000 EUDAMED120SX000/000 EUDAMEDFDA UDI
- Description
- Simulflex Replacement Mattress, 4 Way, 120kg, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056341676003 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
Simulflex 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 b9204e83-b15c-4135-a2b8-e05c08b52c46 61 fields · synced Jul 27, 2026
- FDA UDI 2878f6c8-4094-474e-98f2-b738e732dc18 33 fields · synced May 30, 2026