Class IIa Surgical Instruments
by Biotec S.R.L. EUDAMED
Active
Ref 530HS039Model DRIVER, SCREWDRIVER, WRENCH, IMPLANT DRIVER MINI HANDPIECE, DRILL EXTENSION
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++D748ISODEVICES7W | Date30 Jan 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Class IIa Surgical Instruments
- Model / Reference
- DRIVER, SCREWDRIVER, WRENCH, IMPLANT DRIVER MINI HANDPIECE, DRILL EXTENSION, 530HS039
- Primary DI / UDI-DI
- +D748530HS03909
- Basic UDI-DI
- ++D748ISODEVICES7W
- EMDN Code
- L159099 Odontostomatology instruments, reusable - other
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026774
Other devices from Biotec S.R.L.
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