Root Canal File
by Suzhou Esco Medical Equipment Co., Ltd EUDAMED
Active
Ref HRD3Model HRS1,HRS2,HRS3, HRB1,HRB2,HRB3, HRM1,HRM2,HRM3, HRD1,HRD2,HRD3
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697999159RCF5A | Date13 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Root Canal File
- Model / Reference
- HRS1, HRS2, HRS3, HRB1, HRB2, HRB3, HRM1, HRM2, HRM3, HRD1, HRD2, HRD3
- Primary DI / UDI-DI
- 06979991590453
- Basic UDI-DI
- 697999159RCF5A
- EMDN Code
- Q01010299 Root canal filling devices - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000052833
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Suzhou Esco Medical Equipment Co., Ltd
See all devices from Suzhou Esco Medical Equipment Co., Ltd →
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