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ViSIOScan WR
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7098N002Model Intraoral scanner
by CEFLA s.c.
Identity
- Trade Name
- ViSIOScan WR EUDAMEDNewTom FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- The intraoral scanner is a digital optical scanning device used to obtain digital impressions of hard and soft tissues such as teeth, gums, and mucous membrane by means of oral scanning, for oral restoration and orthodontic treatment of malocclusion. The device is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices. FDA UDI
- Model / Reference
- Intraoral scanner EUDAMED7098N002 EUDAMEDVisioScan WR FDA UDI
- Description
- The intraoral scanner is a digital optical scanning device used to obtain digital impressions of hard and soft tissues such as teeth, gums, and mucous membrane by means of oral scanning, for oral restoration and orthodontic treatment of malocclusion. The device is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices. FDA UDI
Identifiers
- Catalog Number
- 7098N001 FDA UDI
- Primary DI / UDI-DI
- 08033837938286 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMINTRSC1001D2 EUDAMED
- Direct Marketing DI
- 08033837938286 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
ViSIOScan WR by CEFLA s.c. — 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 | 803383793IMINTRSC1001D2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (2)
- EUDAMED 8038ed56-b189-451d-939f-6eaef71d65aa 61 fields · synced Jul 16, 2026
- FDA UDI 9656ccd7-5b2e-444f-bdb7-26234c8c9730 36 fields · synced May 29, 2026