Denflex Spring Endo file
by Denflex Co., Ltd. EUDAMED 24 variants
Active
Ref SFTG6HL25#20F-B, SFTG6HL25#50R-B, SFTG6HL25#25F-S, SFTG6HL25#30R-B, SFTG6HL25#15F-S, SFTG6HL25#15R-S, SFTG6HL25#10R-S, SFTG6HL23#20R-B, SFTG6HL23#15R-S, SFTG6HL25#30F-S, SFTG6HL25#15R-B, SFTG6HL23#25F-S, SFTG6HL25#20R-S, SFTG6HL25#50F-S, SFTG6HL25#30F-B, SFTG6HL23#20F-S, SFTG6HL25#50R-S, SFTG6HL23#20R-S, SFTG6HL23#30F-B, SFTG6HL23#25F-B, SFTG6HL25#40R-B, SFTG6HL25#25F-B, SFTG6HL23#15F-B, SFTG6HL23#15F-S, SFPATHHL23#00F, SFTG6HL23#10F-S, SFTG6HL25#10F-B
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800181602183 | Date29 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- SFTG6HL25#20F-B, SFTG6HL25#50R-B, SFTG6HL25#25F-S, SFTG6HL25#30R-B, SFTG6HL25#15F-S, SFTG6HL25#15R-S, SFTG6HL25#10R-S, SFTG6HL23#20R-B, SFTG6HL23#15R-S, SFTG6HL25#30F-S, SFTG6HL25#15R-B, SFTG6HL23#25F-S, SFTG6HL25#20R-S, SFTG6HL25#50F-S, SFTG6HL25#30F-B, SFTG6HL23#20F-S, SFTG6HL25#50R-S, SFTG6HL23#20R-S, SFTG6HL23#30F-B, SFTG6HL23#25F-B, SFTG6HL25#40R-B, SFTG6HL25#25F-B, SFTG6HL23#15F-B, SFTG6HL23#15F-S, SFPATHHL23#00F, SFTG6HL23#10F-S, SFTG6HL25#10F-B
- Primary DI / UDI-DI
- 08800181602183, 08800181602541, 08800181602213, 08800181602503, 08800181602138, 08800181602374, 08800181602336, 08800181602404, 08800181602350, 08800181602251, 08800181602381, 08800181602190, 08800181602411, 08800181602299, 08800181602268, 08800181602152, 08800181602534, 08800181602398, 08800181602244, 08800181602206, 08800181602527, 08800181602220, 08800181602121, 08800181602114, 08800181602558, 08800181602077, 08800181602107
- Basic UDI-DI
- B-08800181602183, B-08800181602541, B-08800181602213, B-08800181602503, B-08800181602138, B-08800181602374, B-08800181602336, B-08800181602404, B-08800181602350, B-08800181602251, B-08800181602381, B-08800181602190, B-08800181602411, B-08800181602299, B-08800181602268, B-08800181602152, B-08800181602534, B-08800181602398, B-08800181602244, B-08800181602206, B-08800181602527, B-08800181602220, B-08800181602121, B-08800181602114, B-08800181602558, B-08800181602077, B-08800181602107
- EMDN Code
- Q010199 Conservative dentistry and endodontics devices - other
- Device Class
- Class IIa
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- KR-MF-000030617
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Denflex Co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Implantable: 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