Identity
- Trade Name
- EZPZ-SP EUDAMEDEZPZ 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. The EZPZ-SP is a mobile shower commode chair featuring a height-adjustable aluminum frame, molded contoured seat and back support, flip up arm supports, swing away leg supports, two dual-locking 5” (125mm) casters, two large rear wheels with ergonomic handrims and commode pan. FDA UDI
- Model / Reference
- EZ205 EUDAMEDEZPZ-SP FDA UDI
- Description
- Individually configured, mobile and stationary commode chairs for use during showering and toileting. The EZPZ-SP is a mobile shower commode chair featuring a height-adjustable aluminum frame, molded contoured seat and back support, flip up arm supports, swing away leg supports, two dual-locking 5” (125mm) casters, two large rear wheels with ergonomic handrims and commode pan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628758002055 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
Ezpz-Sp by Raz Design Inc — 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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- 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 0412f79b-3284-42a8-9f0c-ab7ecb008376 61 fields · synced Jul 28, 2026
- FDA UDI bd238a7c-edf2-4ffb-a70a-ea2d8fe02df3 34 fields · synced May 30, 2026