Um-1l
by Changzhou Sifary Medical Technology Co., Ltd. 2 variants
Ref 6680035Model UM-1L
Active
CE MDR
Valid until
14 Aug 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000328670 | Date24 Sep 2026 | StatusActive |
Certificates
- 1000328670 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 24 Sep 2026
- Expires
- 14 Aug 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Handpiece of Ultrasonic Scaler
- Model / Reference
- UM-1L, 6680035
- Primary DI / UDI-DI
- 06972597782338
- Basic UDI-DI
- 697259778ES004NY
- Direct Marketing DI
- 06972597782338
- EMDN Code
- Z12110101 Dental treatment units
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000010405
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Changzhou Sifary Medical Technology Co., Ltd.
See all devices from Changzhou Sifary Medical Technology 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