Identity
- Trade Name
- Advanced Bath Chair EUDAMEDLeckey Advanced Bath Chair FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Bathing EUDAMEDThe Advanced Bath Chair provides the user with the appropriate levels of postural support ensuring they are safe and secure at all times during bathing. FDA UDI
- Model / Reference
- LAB EUDAMEDAdvanced Bath Chair FDA UDI
- Description
- The Advanced Bath Chair provides the user with the appropriate levels of postural support ensuring they are safe and secure at all times during bathing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804500006 EUDAMEDFDA UDI
- Basic UDI-DI
- 05059804104Bathing7L EUDAMED
- Direct Marketing DI
- 05059804500006 EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Shower seat, non-powered 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
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
Yes
FDA UDI
Category: Hydrotherapy bath/tank
Advanced Bath Chair by James Leckey Design Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Hydrotherapy bath/tank.
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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 | 05059804104Bathing7L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- James Leckey Design Ltd
- EUDAMED SRN
- XI-MF-000003572
Sources (2)
- EUDAMED 631f2d71-4b9f-4628-88bd-b7039c5b502e 61 fields · synced Jul 9, 2026
- FDA UDI 1c85edea-90a7-405d-aa04-3d78ef1f9e3b 33 fields · synced May 30, 2026