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Uni-Fix Raised Toilet Seat
EUDAMEDFDA UDIClass I (EU MDR)
Ref HA0600Model UNI-FIX RAISED TOILET SEAT
Identity
- Trade Name
- UNI-FIX RAISED TOILET SEAT EUDAMEDRAISED TOILET SEAT FDA UDI
- Generic Name
- Raised toilet seat FDA UDI
- Device Name
- UNI-FIX RAISED TOILET SEAT EUDAMEDRAISED TOILET SEAT FDA UDI
- Model / Reference
- UNI-FIX RAISED TOILET SEAT EUDAMEDHA0600 EUDAMEDUNI-FIX FDA UDI
- Description
- RAISED TOILET SEAT FDA UDI
Identifiers
- Catalog Number
- HA0600 FDA UDI
- Primary DI / UDI-DI
- 05050962002036 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050962RAISEDTOILETSEATRA EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y091215 TOILET SEATS, RAISED EUDAMED
- GMDN Term
- Raised toilet seat FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Northern Ireland 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
No
FDA UDI
Uni-Fix Raised Toilet Seat by Helping Hand Company (Ledbury) Ltd — 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 | 5050962RAISEDTOILETSEATRA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Helping Hand Company (Ledbury) Ltd
- EUDAMED SRN
- GB-MF-000011951
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED 72d96d9f-519d-4f70-958f-875422e15a7c 61 fields · synced Oct 7, 2026
- FDA UDI a0f5f9e0-8af2-4bc4-8d6c-e8bc6d157f0f 35 fields · synced May 30, 2026