AF BLUE R3s
by Shanghai Fanta Dental Materials Co., Ltd
Ref A05S 2304 021 015Model AF ROTARYs/AF BLUE ROTARYs/AF BLUE R3s/AF BABYs/AF BLUE S ONEs/AF F ONEs/AF F ONE BLUEs/AF PRO GOLDs/RISING ROTARY FILEs/HARMONY ROTARY FILEs/R ONE MINI KITs
Active
CE MDR
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/MDR | Number697492976AS0009MF 06942049593010 | Date6 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile Root Canal Files
- Model / Reference
- AF ROTARYs/AF BLUE ROTARYs/AF BLUE R3s/AF BABYs/AF BLUE S ONEs/AF F ONEs/AF F ONE BLUEs/AF PRO GOLDs/RISING ROTARY FILEs/HARMONY ROTARY FILEs/R ONE MINI KITs, A05S 2304 021 015
- Primary DI / UDI-DI
- 06942049593010
- Basic UDI-DI
- 697492976AS0009MF
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000017176
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Shanghai Fanta Dental Materials Co., Ltd
See all devices from Shanghai Fanta Dental Materials Co., Ltd →
Properties
Other properties (12)
- 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