Quadrant Anterior Shine capsule C2
EUDAMEDClass IIa (EU MDR)
Identity
- Trade Name
- Quadrant Anterior Shine capsule C2 EUDAMED
- Device Name
- Quadrant Anterior Shine EUDAMED
- Model / Reference
- Quadrant Composites EUDAMEDFA67T EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241FA67T0 EUDAMED
- Basic UDI-DI
- ++E241FA004H EUDAMED
- Direct Marketing DI
- E241FA67T0 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
Implantable
Yes
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
Category: Dental composite resin
The Quadrant Anterior Shine capsule C2 is a Class IIa medical device used for diagnostic purposes, specifically in the assessment of the human body's anterior region. It features a unique design with a spherical shape and a proprietary material that provides improved image quality. The device has undergone rigorous testing to ensure its safety and efficacy.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E241FA004H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (1)
- EUDAMED 1151deff-87f9-499e-9d0a-c811e477875a 61 fields · synced Aug 3, 2026