Stopper Drill
by MegaGen Implant Co., Ltd. 72 variants
Ref R2UD5813
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 | Number880972899144Q5 08809854027988 | Date4 Sep 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- Withdrawn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
- Stopper Drill
- Model / Reference
- R2UD5813
- Primary DI / UDI-DI
- 08809854027988
- Basic UDI-DI
- 880972899144Q5
- EMDN Code
- L159099 Odontostomatology instruments, reusable - other
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- KR-MF-000009885
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Megagen Implant Co., Ltd.
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