UltraMax
by Marlen Mfg. & Development Co. EUDAMED
Active
Ref 595222
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0661613ILEOPOUCHESNC | Date14 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Ileostomy Pouch
- Model / Reference
- 595222
- Primary DI / UDI-DI
- 00661613002432
- Basic UDI-DI
- 0661613ILEOPOUCHESNC
- Unit of Use DI
- 00661613002425
- EMDN Code
- A1001020102 One-piece ileostomy bags for non-retracted stoma, flat, 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