Elkofast gel 0.3%
by L. Molteni & C. dei F.lli Alitti - Società di Esercizio - S.p.A. Italy EUDAMED
Ref TH006A20 EMDN M040499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805759204SBMDPDTUN | Date13 Mar 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CSQ0017240124 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 9 Jan 2024
- Expires
- 8 Jan 2029
- Reason
- Add device or group
Specification
- Device Name
- Substance Based Medical Device PhotoDynamicTherapy
- Model / Reference
- TH006A20
- Primary DI / UDI-DI
- 08057592040053
- Basic UDI-DI
- 805759204SBMDPDTUN
- EMDN Code
- M040499 Dressings for wounds, sores and ulcerations - other
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000038763
Other devices from L. Molteni & C. dei F.lli Alitti - Società di Esercizio - S.p.A.
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 8cd49d06-45a6-4b2b-9395-417fcc9b2046