Vera By Young™ Contra Soft Elite Original™
by Young Dental Manufacturing I, LLC United States EUDAMEDGUDID
Ref 161025Model Disposable Prophy Angle
Product code EGSEMDN Q01010403
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | NumberB-10302731610259 | Date21 Nov 2022 | StatusActive |
| European Union | CE/MDD EUDAMED | NumberB-10302731610259 | Date21 Nov 2022 | StatusActive |
| United States | GUDID listing GUDID | Number10302731610259 | Date16 Oct 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Vera By Young™ Contra Soft Elite Original™ EUDAMEDYoung GUDID
- Generic Name
- Dental polishing cup, single-use
- Model / Ref / Catalog
- 161025, Disposable Prophy Angle
- Primary DI / UDI-DI
- 10302731610259 EUDAMED00302731610252 GUDID
- Basic UDI-DI
- B-10302731610259, 03027346938K780752EGSK4
- FDA Product Code
- EGS
- EMDN Code
- Q01010403 Dental abrasive and polishing materials
- GMDN Term
- Dental polishing cup, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.4200
- Market of Registration
- SwedenIreland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 10302731610259 | 00302731610252 |
| Device Class | Class IIa | Class I |
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 & raw data
Show properties, registry sources and raw records
Other properties (19)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (3)
- EUDAMED af6b4c30-8180-4b7a-a24f-6a12e97dbb94
- FDA UDI 291dddb4-b3d0-499d-8f3f-85289bdb9024
- EUDAMED 10302731610259|03027346938K780752EGSK4