H FILES（NiTi）
by Shandong Hengfeng Kerui Medical Equipment Co., Ltd China EUDAMED
Ref NTH 2102 008Model 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 EMDN Q01010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69363400DRCI001H3 | Date19 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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, NTH 2102 008
- Primary DI / UDI-DI
- 06936340006638, 06936340006621
- Basic UDI-DI
- 69363400DRCI001H3
- EMDN Code
- Q01010299 Root canal filling devices - other
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000042567
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shandong Hengfeng Kerui Medical Equipment Co., Ltd
See all devices from Shandong Hengfeng Kerui Medical Equipment Co., Ltd →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED dbda9b76-463a-4d8c-99d7-4c41f00608e9
- EUDAMED 06936340006621|69363400DRCI001H3