Identity
- Trade Name
- Toto Touch Control Unit - 110v FDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay, reusable FDA UDI
- Device Name
- Toto Touch Control Unit - 110v FDA UDI
- Model / Reference
- Toto EUDAMED4000010 EUDAMEDFDA UDI
- Description
- Toto Touch Control Unit - 110v FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056279304290 EUDAMEDFDA UDI
- Basic UDI-DI
- 50562793Toto4L EUDAMED
- FDA Product Code
- IKZ FDA UDI
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
- GMDN Term
- Alternating-pressure bed mattress overlay, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5225 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
4000010 by Frontier Therapeutics Limited — 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 | 50562793Toto4L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Frontier Therapeutics Limited
- EUDAMED SRN
- GB-MF-000035429
- Authorised Representative
- Frontier Medical Germany GmbH DE-AR-000031721
Sources (2)
- EUDAMED 196819da-3168-448d-bb6b-8c4d909351d3 61 fields · synced Jun 18, 2026
- FDA UDI d4622a37-3978-44bb-ace2-6c07e7a92dd8 34 fields · synced May 30, 2026