Dental Implants
by Biotec S.R.L. Italy EUDAMED
Ref 111EW50MModel TWO EV, BT KLASSIC, BT KONIC, BT EVO, BT SAFE, BT NANO, IS KONE, IS+, BT RHYNO, EC+, IC+, GENESYS, BT RHYNO-SHIFT, ULTRA, PTERIGO, MINI, TWO
EMDN P01020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++D748CLASSICIMPWE | Date30 Jan 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 007-00-06-MDR Supplemented
Quality management system EU MDR
- Notified body
- ITALCERT SRL 0426
- Issued
- 27 Apr 2026
- Expires
- 20 Dec 2027
- Reason
- Add device or group
- 008-00-04-MDR Supplemented
Technical documentation EU MDR
- Notified body
- ITALCERT SRL 0426
- Issued
- 5 Mar 2026
- Expires
- 20 Dec 2027
- Reason
- Add device or group
Specification
- Device Name
- Dental Implants
- Model / Reference
- TWO EV, BT KLASSIC, BT KONIC, BT EVO, BT SAFE, BT NANO, IS KONE, IS+, BT RHYNO, EC+, IC+, GENESYS, BT RHYNO-SHIFT, ULTRA, PTERIGO, MINI, TWO, 111EW50M
- Primary DI / UDI-DI
- +D748111EW50M0K
- Basic UDI-DI
- ++D748CLASSICIMPWE
- EMDN Code
- P01020101 Dental implants
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026774
Other devices from Biotec S.R.L.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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
Sources (1)
- EUDAMED +D748111EW50M0K|++D748CLASSICIMPWE