Fluoride Foam Trays
by Hubei Guarddent Medical Technology Co., Ltd 3 variants
Ref Dual ArchModel Dual Arch:GD-1541、GD-1542、GD-1543、GD-1544、GD-1544G、GD-1541T、GD-1542T、GD-1543T；Single：GD-1545、GD-1546、GD-1547、GD-1548、GD-1548G
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 | Number697565200FFT001ER | Date13 Feb 2026 | 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- Withdrawn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
- Dual Arch:GD-1541、GD-1542、GD-1543、GD-1544、GD-1544G、GD-1541T、GD-1542T、GD-1543T；Single：GD-1545、GD-1546、GD-1547、GD-1548、GD-1548G, Dual Arch
- Primary DI / UDI-DI
- 06975652008114, 06975652008121
- Basic UDI-DI
- 697565200FFT001ER
- EMDN Code
- Q010503 Impression material trays, single-use
- Device Class
- Class I
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000028116
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Hubei Guarddent Medical Technology Co., Ltd
See all devices from Hubei Guarddent 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