Identity
- Trade Name
- Raz ZUM-SP EUDAMEDRaz FDA 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. Folding Self-Propel Mobile Shower Commode Chair with aluminium frame. FDA UDI
- Model / Reference
- Z222 EUDAMEDRaz ZÜM-SP FDA UDI
- Description
- Individually configured, mobile and stationary commode chairs for use during showering and toileting. Folding Self-Propel Mobile Shower Commode Chair with aluminium frame. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628758002222 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
Raz ZUM-SP 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 Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 628758RAZDESIGNINC2004V9 | Class I | Active |
| 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 4811cc2e-570d-4180-9040-7f1aa48b6c0c 61 fields · synced Aug 3, 2026
- FDA UDI 080d2aaa-a192-4390-bc47-a48913d3a236 34 fields · synced May 30, 2026