Bioimaging and radiotherapy instrumentsDigital bioimaging management instruments
Laser imaging scanner
EMDN code Z110601
Manufacturers registered in Europe (EUDAMED) 14
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Aligntech FDA EU representative : Align Technology B.V. (Netherlands) | Israel | I, IIa MDR | Website Quality-legal-EMEA@aligntech.com EUDAMED record Report an error | |
| Cefla FDA | Italy | I, IIa MDR, 93/42 | Website EUDAMED record Report an error | |
| AccuVein FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | I 93/42 | Website EUDAMED record Report an error | |
| Moor FDA EU representative : Advena Limited (Malta) and 1 other | United Kingdom (ex Northern Ireland) |
|
IIa 93/42 | Website EUDAMED record Report an error |
| Planmeca FDA | Finland | I MDR | EUDAMED record Report an error | |
| Voxelcare | Spain | I MDR | Website EUDAMED record Report an error | |
| Alliage S/A Indústrias Médico Odontológica FDA EU representative : ELS SOLUTIONS GDIA - UNIPESSOAL LDA. (Portugal) | Brazil | I MDR | Website EUDAMED record Report an error | |
| Caliber Imaging & Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | IIa 93/42 | EUDAMED record Report an error | |
| DHEF FDA EU representative : Obelis s.a. (Belgium) | Taiwan |
|
I MDR | EUDAMED record Report an error |
| Guilin Yikeshi Medical Instrument FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | I MDR | EUDAMED record Report an error | |
| Inpixel Medical Technology EU representative : Wellkang Ltd (Northern Ireland) | China |
|
I MDR | EUDAMED record Report an error |
| Sopro FDA | France |
|
I MDR | Website info@sopro.acteongroup.com EUDAMED record Report an error |
| Wuhan Ruler Technology EU representative : SUNGO Europe B.V. (Netherlands) | China | I MDR | EUDAMED record Report an error | |
| Ivoclar FDA No model still on the market | Liechtenstein |
|
I MDR | Website EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 14
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| KaVo Dental GmbH Present in Europe in other categories | Germany | DIAGNOcam Vision Full HD DIAGNOdent pen 2190 DEXIS CariVu 3-in-1 by KaVo DIAGNOdent 2095 DIAGNOdent Paro Tip Saphir without scale DIAGNOdent pen 2190 US | K060080 (2006) |
| DÜRR DENTAL SE Present in Europe in other categories | Germany | CamX Triton HD, Cam CamX Triton HD, Cam Proxi CamX Triton HD, Cam Spectra Proxi CamX Triton HD, PROXI Head CamX Triton HD Handpiece CamX Proxi Interchangeable Head | registered |
| Sirona Dental Systems GmbH Present in Europe in other categories | United States | Primescan 2 Primescan 2 Multiuse Sleeve | registered |
| Addent, Inc. | United States | AdDent | K062961 (2007) |
| A-Dec, Inc. | United States | A-dec | registered |
| Zetta25 AG Present in Europe in other categories | – | DI Scan | registered |
| D4D Technologies | United States | – | K213482 (2022) |
| DENTSPLY SIRONA INC | United States | – | K250771 (2025) |
| Duerr Dental AG Present in Europe in other categories | Germany | – | K172007 (2017) |
| FABRINET CO., LTD. | Thailand | – | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | – | registered |
| I-Dent Innovations for Dentistry SA | Switzerland | – | registered |
| JENOPTIK Optical Systems GmbH | Germany | – | registered |
| Kaltenbach & Voigt GmbH | Germany | – | K182712 (2019) |
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