Identity
- Trade Name
- Simplex Badeliege EUDAMEDSimplex bath chair FDA UDI
- Generic Name
- Bathing/changing table, mobile FDA UDI
- Device Name
- Alltagshilfen EUDAMED
- Model / Reference
- 9800021602000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04034089082196 EUDAMEDFDA UDI
- Basic UDI-DI
- 4034089AlltagshilfenJ8 EUDAMED
- Direct Marketing DI
- 04034089082196 EUDAMED
- FDA Product Code
- KTC FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Bathing/changing table, mobile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5125 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hydrotherapy bath/tank
Simplex Badeliege by Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 4034089AlltagshilfenJ8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- DE-MF-000006303
Sources (2)
- EUDAMED ecd1fc15-168a-4675-a1bf-46a6df622ec5 61 fields · synced Jul 19, 2026
- FDA UDI 921b4b37-6d0c-4438-b0ea-669fdfa80398 32 fields · synced May 30, 2026