Degasil® Simeticonă 280 mg
by WALMARK, a.s. EUDAMED
Active
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2026-MDR/QS-011/B | Date27 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2026-MDR/QS-011/B Amended
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 27 Aug 2026
- Expires
- 30 Jan 2031
- Reason
- Other
- 2026-MDR/TD-011/B Amended
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 27 Aug 2026
- Expires
- 30 Jan 2031
- Reason
- Other
Specification
- Device Name
- Degasin 280 mg
- Primary DI / UDI-DI
- 08596024030014
- Basic UDI-DI
- 8596024DEGASIN280MG2K
- EMDN Code
- G99 Gastrointestinal devices - other
- Device Class
- Class III
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CZ-MF-000007035
Other devices from WALMARK, a.s.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No