Root Canal File
by Suzhou Esco Medical Equipment Co., Ltd 12 variants
Ref HRB2Model HRS1,HRS2,HRS3, HRB1,HRB2,HRB3, HRM1,HRM2,HRM3, HRD1,HRD2,HRD3
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697999159RCF5A 06979991590385 | Date13 Jul 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Root Canal File
- Model / Reference
- HRS1, HRS2, HRS3, HRB1, HRB2, HRB3, HRM1, HRM2, HRM3, HRD1, HRD2, HRD3
- Primary DI / UDI-DI
- 06979991590385
- Basic UDI-DI
- 697999159RCF5A
- EMDN Code
- Q01010299 Root canal filling devices - other
- Device Class
- Class I
- EU 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