Excalibur PRO Mini sterile files
by Shenzhen Denco Medical Co., Ltd. 6 variants
Ref ZRE31PROMI25Model Excalibur PRO Mini sterile files 31mm E25 (6 units)
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-06942512514993 06942512514993 | Date6 Mar 2026 | 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- Withdrawn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
- Model / Reference
- Excalibur PRO Mini sterile files 31mm E25 (6 units), ZRE31PROMI25
- Primary DI / UDI-DI
- 06942512514993
- Basic UDI-DI
- B-06942512514993
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- EU market of registration
- Spain
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 (10)
- 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