2 tone solution 4 gallon
by Young Dental Manufacturing I, LLC
Ref 233004Model Plaque Dislcosing Products
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number03027360408D530780QJCSZ 10302732330040 | Date21 Feb 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10302732330040 | Date17 Feb 2025 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- 2 tone solution 4 gallon EUDAMEDYoung Dental GUDID
- Generic Name
- Dental caries detecting stain
- Model / Ref / Catalog
- Plaque Dislcosing Products, 233004
- Primary DI / UDI-DI
- 10302732330040 EUDAMED00302732330043 GUDID
- Basic UDI-DI
- 03027360408D530780QJCSZ
- FDA Product Code
- QJC
- EMDN Code
- Q019003 Dental floss and other devices for oral hygiene (for professional use)
- GMDN Term
- Dental caries detecting stain
- Device Class
- Class I
- Regulation Number
- 872.6855
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 10302732330040 | 00302732330043 |
Manufacturer details
- EUDAMED SRN
- US-MF-000027132
- Authorised representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Other devices from Young Dental Manufacturing I, LLC
Properties
Other properties (19)
- Sterile: No
- Single Use: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No