Optolab 3DTechnologies Limited
Ireland IE-MF-000051764 Last updated 21 Oct 2026
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- Devices
- 3
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
About
Optolab delivers comprehensive vision screening in minutes, empowering local optometrists to transform the lives of children in their communities.
What Optolab 3DTechnologies Limited makes
Optolab 3DTechnologies Limited manufactures vision screening devices, including the Ilert v10, Ilert CVT, and Ilert models, designed for rapid assessment of children’s eyesight in clinical settings. These devices are intended for use by optometrists to evaluate visual acuity and other key metrics within a short timeframe. The portfolio focuses on portable, user-friendly solutions for early detection of vision-related issues in pediatric patients.
The company’s devices are classified under EU Medical Device Regulation as Class I, ensuring compliance with basic safety and performance requirements. These products are registered in the EU’s eudamed database, a mandatory listing for medical devices marketed within the European Economic Area. Optolab 3DTechnologies Limited is based in Ireland.
Frequently asked questions
What types of medical devices does Optolab 3DTechnologies Limited manufacture?
Optolab 3DTechnologies Limited specializes in vision screening devices, including models like the Ilert v10, Ilert CVT, and Ilert. These devices are designed for optometrists to quickly assess children’s visual acuity and other key eye health metrics in clinical settings. The focus is on delivering portable, efficient solutions for early detection of vision issues in pediatric patients.
Where is Optolab 3DTechnologies Limited based?
Optolab 3DTechnologies Limited is headquartered in Ireland. The company’s location supports its operations in developing and distributing vision screening devices tailored for use in clinical environments, particularly for pediatric eye health assessments.
Which regulatory registries list Optolab 3DTechnologies Limited’s devices?
Optolab 3DTechnologies Limited’s devices are listed in the eudamed database, which is the official EU registry for medical devices marketed within the European Economic Area. Listing in eudamed is mandatory for compliance with EU Medical Device Regulation requirements.
How are Optolab 3DTechnologies Limited’s devices classified under EU regulations?
Optolab 3DTechnologies Limited’s vision screening devices, such as the Ilert series, are classified under Class I in the EU Medical Device Regulation. This classification applies to devices posing minimal risk, where general safety and performance requirements are sufficient to ensure compliance. The classification reflects the low-risk nature of these screening tools for optometrists.
Information
- Country
- Ireland
- Address
- Kilmurray, Co. Meath, Ireland
- Website
- www.optolab3d.com
- [email protected]
- Phone
- 353-469436223
- PRRC contact
- Valerie Kennelly
- EUDAMED SRN
- IE-MF-000051764