Dental Sectional Contoured Matrices Kits
by Huanghua Promisee Dental Co.Ltd.
Ref SC1809Model SC01,SC1001,SC1101,SC0103,SC0104, SC1002,SC1102,SC15,SC1502,SC1503, SC1801,SC1802,SC1803,SC1804
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69544540DSCM001PC 06954454016114 | Date7 Mar 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- SC01, SC1001, SC1101, SC0103, SC0104, SC1002, SC1102, SC15, SC1502, SC1503, SC1801, SC1802, SC1803, SC1804, SC1809
- Primary DI / UDI-DI
- 06954454016114
- Basic UDI-DI
- 69544540DSCM001PC
- EMDN Code
- Q01010199 Dental restoration devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000014766
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Huanghua Promisee Dental 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