Abiojoint EVO
Ref 11021
Active
CE MDR
Valid until
19 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805651586P90040211001ZL 08056515860747 | Date29 May 2026 | StatusActive |
Certificates
- CSQ003426 Active
Quality management system EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 20 Mar 2026
- Expires
- 19 Mar 2031
- CVD005726 Active
Technical documentation EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 20 Mar 2026
- Expires
- 19 Mar 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- ABIO32/18
- Model / Reference
- 11021
- Primary DI / UDI-DI
- 08056515860747
- Basic UDI-DI
- 805651586P90040211001ZL
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- IT-MF-000029973
Other devices from Abiogen Pharma S.p.A.
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