Melilax
by Aboca S.P.A. Società Agricola Italy EUDAMED
Ref 08032472009801
EMDN G05
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0009231226 | Date30 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 1 country, as listed in EUDAMED:
- Romania
Certificates
- CSQ0009231226 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 30 Sep 2026
- Expires
- 26 Mar 2028
- Reason
- Add device or group
- CVD005626 Issued
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 25 Feb 2026
- Expires
- 26 Mar 2028
Specification
- Device Name
- Melilax microclismi
- Model / Reference
- 08032472009801
- Primary DI / UDI-DI
- 08032472009801
- Basic UDI-DI
- 8032472MEXax1ZW
- EMDN Code
- G05 Topical anorectal administered gastro-intestinal system devices
- Device Class
- Class III
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- IT-MF-000029499
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED f158469d-10e0-4dea-8fb7-fb3c43ca8ae5