Identity
- Trade Name
- Raz-SP600 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-SP600 is a Heavy Duty Mobile Shower Commode Chair with stainless steel frame and components, two locking 6” (150mm) casters, two large rear wheels with ergonomic handrims, and commode pan. FDA UDI
- Model / Reference
- Z260 EUDAMEDRaz-SP600 FDA UDI
- Description
- Individually configured, mobile and stationary commode chairs for use during showering and toileting. The Raz-SP600 is a Heavy Duty Mobile Shower Commode Chair with stainless steel frame and components, two locking 6” (150mm) casters, two large rear wheels with ergonomic handrims, and commode pan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628758002604 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
Raz-SP600 by Raz Design Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 9ffac599-a84d-47de-a8f7-da604430052a 61 fields · synced Jul 17, 2026
- FDA UDI 35469efe-0cfb-4003-91e1-5f109045de42 34 fields · synced May 30, 2026