Monomanual I/A System reusable
by Bürki inno med AG 13 variants
Ref SL 116 s3
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764013745P02P04X4 07640137451813 | Date24 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- I/A System reusable
- Model / Reference
- SL 116 s3
- Primary DI / UDI-DI
- 07640137451813
- Basic UDI-DI
- 764013745P02P04X4
- Direct Marketing DI
- 07640137451813
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000017443
- Authorised representative
- Bürki inno med GmbH DE-AR-000008073
From the manufacturer
Manufacturer's product page: Monomanual I/A System reusable (SAFE-LOCK I/A Coaxial System)
Other devices from Bürki inno med AG
Properties
Other properties (12)
- Sterile: No
- Implantable: 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