Dental Root-canal Instruments
by Shenzhen Superline Technology Co., Ltd. 304 variants
Ref AA29104D6PModel Files
Active
CE MDD
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/MDD | NumberB-06944835147995 06944835147995 | Date11 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Dental Root-canal Instruments
- Model / Reference
- Files, AA29104D6P
- Primary DI / UDI-DI
- 06944835147995
- Basic UDI-DI
- B-06944835147995
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000027059
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Shenzhen Superline Technology Co., Ltd.
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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