UltraMax Gemini
by Marlen Mfg. & Development Co. EUDAMED
Active
Ref 20022
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0661613OSTOMYFLANGEC7 | 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- Withdrawn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
- Ostomy Flange
- Model / Reference
- 20022
- Primary DI / UDI-DI
- 00661613004917
- Basic UDI-DI
- 0661613OSTOMYFLANGEC7
- Unit of Use DI
- 00661613004900
- EMDN Code
- A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
- 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