Root Canal File
by Chengdu Sani Medical Equipment Co., Ltd. China EUDAMED
Model K Files 21mm 06 EMDN L159004
Overview
The Root Canal File is a precision instrument designed for root canal treatments, offering unparalleled accuracy and safety. Utilizing advanced technology, this device provides enhanced efficiency while minimizing the risk of complications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697060203RCF0016T | Date8 Aug 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- K Files 21mm 06
- Primary DI / UDI-DI
- 06970602031532
- Basic UDI-DI
- 697060203RCF0016T
- EMDN Code
- L159004 Endodontic rasps and files, reusable
- Device Class
- Class I
- Market of Registration
- Cyprus
Manufacturer details
- EUDAMED SRN
- CN-MF-000011715
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 4c880917-caca-4542-a1de-d6b7edbc7ec7