Vitrectomy Dual Cutter 23G - Connector A-A
Ref AK-0238/AA2Model Vitrectomy Cutter/Vitrectomo
Active
CE MDR
Valid until
13 Dec 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberEPT 0477.MDR.22/5010.1 | Date30 Aug 2023 | StatusActive |
Certificates
- EPT 0477.MDR.22/5010.1 Active
Quality management system EU MDR
- Certifier
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 30 Aug 2023
- Expires
- 13 Dec 2027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Vitrectomy Cutter/Vitrectomo
- Model / Reference
- Vitrectomy Cutter/Vitrectomo, AK-0238/AA2
- Primary DI / UDI-DI
- 08052276034205
- Basic UDI-DI
- 8052276FT0003HJ
- Unit of Use DI
- 08052276034199
- EMDN Code
- Q020499 Vitrectomy devices - other
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000007813
Other devices from Aktive SRL
Properties
Other properties (12)
- 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