Identity
- Trade Name
- Zwim EUDAMEDFDA UDI
- Generic Name
- Commode, manual FDA UDI
- Device Name
- Washing, Bathing and Showering Devices - Other EUDAMEDIndividually configured, mobile and stationary commode chairs for use during showering and toileting. Zwim is a Self-Propel Mobile Shower / Pool (Commode) Chair with an aluminum frame. FDA UDI
- Model / Reference
- EP900 EUDAMEDZwim FDA UDI
- Description
- Individually configured, mobile and stationary commode chairs for use during showering and toileting. Zwim is a Self-Propel Mobile Shower / Pool (Commode) Chair with an aluminum frame. FDA UDI
Identifiers
- Catalog Number
- EP900 FDA UDI
- Primary DI / UDI-DI
- 00628758009009 EUDAMEDFDA UDI
- Basic UDI-DI
- 628758RAZDESIGNINC2004V9 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Commode, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hydrotherapy bath/tank
Zwim by Raz Design Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hydrotherapy bath/tank.
- Harmony Bath — Arjohuntleigh, Inc. · Class II
- CRYSTAL ELECTRIQUE — France Reval · Class I
- Harmony Bath — Arjohuntleigh, Inc. · Class II
- commode chair — Zhenjiang U-Nurse Medical Equipment Co.,Ltd · Class I
- Primo — Arjohuntleigh, Inc. · Class II
- Primo Ferro — Arjohuntleigh, Inc. · Class II
- Primo — Arjohuntleigh, Inc. · Class II
- Haltegriff Edelstahl, 40 cm — Ludwig Bertram GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 628758RAZDESIGNINC2004V9 | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Raz Design Inc.
- EUDAMED SRN
- CA-MF-000004895
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e11fc3f0-f3d8-4585-9e8f-249bf2561498 61 fields · synced Jun 18, 2026
- FDA UDI 2dbab5e0-5b40-4dc1-9a21-ab26f9a55f26 35 fields · synced May 27, 2026