NiTi Reamers
by Shenzhen Denco Medical Co., Ltd. 105 variants
Ref CODE52R25NT35Model E52 NiTi Reamers 6s 25mm No.35
Active
CE MDD
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/MDD | NumberB-06942512507278 06942512507278 | Date28 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- Withdrawn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/MDD Active
Specification
- Device Name
- Dental Root Canal Instruments Files
- Model / Reference
- E52 NiTi Reamers 6s 25mm No.35, CODE52R25NT35
- Primary DI / UDI-DI
- 06942512507278
- Basic UDI-DI
- B-06942512507278
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000014271
- Authorised representative
- Share info GmbH DE-AR-000005132
Other devices from Shenzhen Denco Medical Co., Ltd.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No