Identity
- Trade Name
- Raz-AT600 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. The Raz-AT600 is a Heavy Duty Mobile Shower Commode Chair (up to 600 lb weight capacity) with stainless steel frame and components, four locking 6” (150mm) casters and commode pan. The specially engineered, Weight Assist Spring System (WASS) is available in two weight ranges and is adjustable to accommodate the user’s weight and Center of Mass (CoM) for tilt operation with minimal effort by the attendant. The AT600 has 25o tilt range to assist with pressure reduction and redistribution, postural support, comfort, and transfers. FDA UDI
- Model / Reference
- Z360 EUDAMEDRaz-AT600 FDA UDI
- Description
- Individually configured, mobile and stationary commode chairs for use during showering and toileting. The Raz-AT600 is a Heavy Duty Mobile Shower Commode Chair (up to 600 lb weight capacity) with stainless steel frame and components, four locking 6” (150mm) casters and commode pan. The specially engineered, Weight Assist Spring System (WASS) is available in two weight ranges and is adjustable to accommodate the user’s weight and Center of Mass (CoM) for tilt operation with minimal effort by the attendant. The AT600 has 25o tilt range to assist with pressure reduction and redistribution, postural support, comfort, and transfers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628758003601 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-AT600 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 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 c0b73f71-3432-4dce-a751-27228a2fa2f6 61 fields · synced Jul 10, 2026
- FDA UDI f4b2596a-36ed-40bd-83c8-e44eec180e9f 34 fields · synced May 30, 2026