GUM® ORTHO ALIGNER per allineatori e apparecchi di contenzione
by Fittydent International GmbH
Ref GUM01
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 | Number9002240RTgum5L 09002240000643 | Date20 May 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- Withdrawn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
- Device Name
- Cleansing Tablets
- Model / Reference
- GUM01
- Primary DI / UDI-DI
- 09002240000643
- Basic UDI-DI
- 9002240RTgum5L
- EMDN Code
- Q010280 Prosthetic dentistry devices - accessories
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- AT-MF-000016986
Other devices from FITTYDENT INTERNATIONAL GmbH
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