K Files
by Shandong Hengfeng Kerui Medical Equipment Co., Ltd 85 variants
Ref SSK 2102 035Model SST Hand Files List of models: SSK 2102 006, SSK 2502 006, SSK 2802 006, SSK 3102 006, SSK 2102 008, SSK 2502 008, SSK 2802 008, SSK 3102 008, SSK 2102 010, SSK 2502 010,SSK 2802 010,etc
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 | Number69363400DRCI001H3 | Date19 May 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- Withdrawn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
- Dental Root Canal Instruments
- Model / Reference
- SST Hand Files List of models: SSK 2102 006, SSK 2502 006, SSK 2802 006, SSK 3102 006, SSK 2102 008, SSK 2502 008, SSK 2802 008, SSK 3102 008, SSK 2102 010, SSK 2502 010, SSK 2802 010, etc, SSK 2102 035
- Primary DI / UDI-DI
- 06936340000162, 06936340000179
- Basic UDI-DI
- 69363400DRCI001H3
- EMDN Code
- Q01010299 Root canal filling devices - other
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000042567
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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See all devices from Shandong Hengfeng Kerui 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