UltraMax
by Marlen Mfg. & Development Co. EUDAMED
Active
Ref 595619
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0661613UROPOUCHESLA | Date14 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Urostomy Pouch
- Model / Reference
- 595619
- Primary DI / UDI-DI
- 00661613004511
- Basic UDI-DI
- 0661613UROPOUCHESLA
- Unit of Use DI
- 00661613004504
- EMDN Code
- A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000055888
- Authorised representative
- AR Experts B.V. NL-AR-000023989
Other devices from Marlen Mfg. & Development Co.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No