PDF-Gel
Ref PDF-GEL1003
Active
CE MDR
Valid until
5 Oct 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number031-00-02-MDR | Date30 Jan 2026 | StatusActive |
Certificates
- 031-00-02-MDR Active
Quality management system EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 30 Jan 2026
- Expires
- 5 Oct 2028
- Reason
- Other
- 032-00-01-MDR Active
Technical documentation EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 30 Jan 2026
- Expires
- 5 Oct 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterify Gel
- Model / Reference
- PDF-GEL1003
- Primary DI / UDI-DI
- 08059388850419
- Basic UDI-DI
- 80593888501W4
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000032120
Other devices from Sterify S.R.L.
Properties
Other properties (11)
- 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