Simethicon 80 mg
by Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A. Poland EUDAMED
Ref _
EMDN G0401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1434-MDR-004/2026 | Date12 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 1434-MDR-004/2026 Issued
Technical documentation EU MDR
- Notified body
- POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. 1434
- Issued
- 12 Feb 2026
- Expires
- 11 Feb 2031
Specification
- Device Name
- Kapsułki miękkie z symetykonem (Soft capsules with simethicone)
- Model / Reference
- _
- Primary DI / UDI-DI
- 05904055006237
- Basic UDI-DI
- 5904055001KQ3
- EMDN Code
- G0401 Orally administered devices for the therapy of gastro-intestinal disorders
- Device Class
- Class III
- Market of Registration
- Slovakia
Manufacturer details
- EUDAMED SRN
- PL-MF-000009264
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 4ef368d3-3957-4ab1-8ded-0b8b255a777c