Gutta Plugger Red 2/3 Silicon Handle
by Mark One Surgical EUDAMED
Active
Ref D-114-744-AModel CARVER
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number896110404CARVER/CLASSIM6 | Date14 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- Withdrawn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
- Device Name
- Interproximal Carver Hollenback, Solid FIG.4
- Model / Reference
- CARVER, D-114-744-A
- Primary DI / UDI-DI
- 08961104041158
- Basic UDI-DI
- 896110404CARVER/CLASSIM6
- EMDN Code
- L159017 Dental restoration carvers, reusable
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- PK-MF-000031202
- Authorised representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Other devices from Mark One Surgical
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