Root canal file
by Jining Orodeka Medical Equipment CO; LTD 254 variants
Ref D-file 008# 25mmModel K - file、R - file、H - file、G - file
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 | Number697284234RCF01KF 06972842343765 | Date13 Feb 2024 | 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- Withdrawn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
- K - file、R - file、H - file、G - file, D-file 008# 25mm
- Primary DI / UDI-DI
- 06972842343765
- Basic UDI-DI
- 697284234RCF01KF
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034133
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Jining Orodeka Medical Equipment CO; LTD
See all devices from Jining Orodeka 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