M3-L
Ref MLP0000021A02Model L/CCEU/CCP/ONE/Mr/RT/OQF/OQFL/Path/GTP/GTPL/T/TE/MAX/AF F ONE/SPathL/Dual Shape One/Shadow/RETREATMENT/Easy Plus/Easy Wave/Easy Baby/Easy Retreatment/Easy Opener/Easy Path/Easy Flex
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 | Number697312285UDGRCF002N7 06942135212269 | Date2 Jun 2023 | 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- Withdrawn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
- Root Canal Files
- Model / Reference
- L/CCEU/CCP/ONE/Mr/RT/OQF/OQFL/Path/GTP/GTPL/T/TE/MAX/AF F ONE/SPathL/Dual Shape One/Shadow/RETREATMENT/Easy Plus/Easy Wave/Easy Baby/Easy Retreatment/Easy Opener/Easy Path/Easy Flex, MLP0000021A02
- Primary DI / UDI-DI
- 06942135212269
- Basic UDI-DI
- 697312285UDGRCF002N7
- EMDN Code
- L159004 Endodontic rasps and files, reusable
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018453
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from United Dental Changzhou
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