High speed air turbine handpieces
by Foshan SOCO Precision Instrument Co., Ltd. 5 variants
Ref SCHG01Model SCHF19,SCHF22,SCHG01,SCHG03,SCHG18
Active
CE MDR 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 | Number697305889100MA | Date2 Jun 2026 | StatusActive |
| European Union | CE/MDR | Number697305889100MA | Date2 Jun 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- Withdrawn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, CE/MDR Active
Specification
- Device Name
- High speed air turbine handpieces
- Model / Reference
- SCHF19, SCHF22, SCHG01, SCHG03, SCHG18
- Primary DI / UDI-DI
- 06973058891002, D-06973058891002W3
- Basic UDI-DI
- 697305889100MA, B-06973058891002W3
- EMDN Code
- Z12110101 Dental treatment units
- Device Class
- Class IIa
- EU market of registration
- FranceCzechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000008758
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Foshan SOCO Precision Instrument Co., Ltd.
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Properties
Other properties (12)
- Sterile: No
- Implantable: 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