Smart Dentin Grinder
by KometaBio Inc EUDAMED
Active
Ref GR101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++D059GR101UT | Date21 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- GR101
- Primary DI / UDI-DI
- ++D059GR101UZ, +D059GR1010R
- Basic UDI-DI
- ++D059GR101UT
- Direct Marketing DI
- ++D059GR101UZ+D059GR1010R
- EMDN Code
- Q010399 Surgical dental devices - other
- Device Class
- Class I
- Market of Registration
- SpainGermany
Manufacturer details
- EUDAMED SRN
- US-MF-000013688
- Authorised representative
- BIONER SA ES-AR-000010785
Other devices from KometaBio Inc
Properties
Other properties (13)
- Sterile: No
- 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