Spreaders（SST）
by Shandong Hengfeng Kerui Medical Equipment Co., Ltd China EUDAMED
Ref SSS 2802 055Model 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
- 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, SSS 2802 055
- Primary DI / UDI-DI
- 06936340020122, 06936340020139
- 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 02be4f42-a456-411a-9688-1f513a4792fa
- EUDAMED 06936340020139|69363400DRCI001H3