Promovia Hydro Balance 100
by Innate s.r.l. EUDAMED 2 variants
Expiring
Ref INN103Model Promovia Hydro Balance Family
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805104033artsyrtreha7EA | Date18 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Certificates
- EPT 0477.MDR.24/5689.1 Expiring
Technical documentation EU MDR
- Notified body
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 14 Jan 2025
- Expires
- 31 Jul 2027
- EPT 0477.MDR.24/5690.1 Expiring
Quality management system EU MDR
- Notified body
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 14 Jan 2025
- Expires
- 31 Jul 2027
Specification
- Device Name
- Promovia Hydro Balance
- Model / Reference
- Promovia Hydro Balance Family, INN103
- Primary DI / UDI-DI
- 08051040331212
- Basic UDI-DI
- 805104033artsyrtreha7EA
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026730
Other devices from Innate 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