H Files
by Shandong Hengfeng Kerui Medical Equipment Co., Ltd EUDAMED
Active
Ref SSH 2502 120Model 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
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- Withdrawn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, SSH 2502 120
- Primary DI / UDI-DI
- 06936340005136, 06936340005129
- 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
Show 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