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2 tone tablets 1000 pk
EUDAMEDFDA UDIClass I (EU MDR)
Ref 234210Model Plaque Dislcosing Products
Identity
- Trade Name
- 2 tone tablets 1000 pk EUDAMEDYoung Dental FDA UDI
- Generic Name
- Dental caries detecting stain FDA UDI
- Device Name
- 2 TONE TABLETS 1000 PK FDA UDI
- Model / Reference
- Plaque Dislcosing Products EUDAMED234210 EUDAMEDFDA UDI
- Description
- 2 TONE TABLETS 1000 PK FDA UDI
Identifiers
- Catalog Number
- 234210 FDA UDI
- Primary DI / UDI-DI
- 10302732342104 EUDAMED00302732342107 FDA UDI
- Basic UDI-DI
- 03027360408D530780QJCSZ EUDAMED
- FDA Product Code
- QJC FDA UDI
- EMDN Code
- Q019003 DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE) EUDAMED
- GMDN Term
- Dental caries detecting stain FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6855 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
2 tone tablets 1000 pk by Young Dental Manufacturing I, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03027360408D530780QJCSZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Dental Manufacturing I, LLC
- EUDAMED SRN
- US-MF-000027132
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 21d25a27-af96-4edc-9792-fd3ad7194aa5 61 fields · synced Oct 6, 2026
- FDA UDI 6106851b-45ee-4797-9201-a5a6435de15c 35 fields · synced May 30, 2026