HM Bohrer RA - rund
by Edenta Etablissement 7 variants
Ref C1SXNZ.204.012Model 10521
Active
CE MDR
Valid until
26 Mar 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000183128 | Date27 Mar 2025 | StatusActive |
Certificates
- 1000183128 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 27 Mar 2025
- Expires
- 26 Mar 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- HM-/Stahl-Bohrer
- Model / Reference
- 10521, C1SXNZ.204.012
- Primary DI / UDI-DI
- E312C1SXNZ2040121
- Basic UDI-DI
- ++E31210521CQ
- Unit of Use DI
- E312C1SXNZ204012101
- EMDN Code
- L159007 Odontostomatology burs, reusable
- Device Class
- Class IIa
- EU market of registration
- Liechtenstein
Manufacturer details
- EUDAMED SRN
- LI-MF-000011937
Other devices from Edenta Etablissement
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