RECIPROC® Minima
by Maillefer Instruments Holding Sàrl 47 variants
Ref MDDRCPM625035Model 10147
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 | Number++J00310147EC | Date18 Sep 2025 | 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- Withdrawn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
- Reciproc NiTi Rotary Single-use Sterile
- Model / Reference
- 10147, MDDRCPM625035
- Primary DI / UDI-DI
- +J003MDDRCPM6250351, J003MDDRCPM6250351
- Basic UDI-DI
- ++J00310147EC
- Unit of Use DI
- J003MDDRCPM6250350
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- EU market of registration
- NetherlandsAustria
Manufacturer details
- EUDAMED SRN
- CH-MF-000016301
- Authorised representative
- Dentsply DeTrey GmbH DE-AR-000005904
Other devices from Maillefer Instruments Holding Sàrl
Properties
Other properties (12)
- 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