LENTILLES
France FR-MF-000006721 Last updated 21 Oct 2026
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- Devices
- 210
- Registries
- EUDAMED
- FDA recalls
- 0
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EUDAMED certificates
Notified body 1639 1 certificate
- FR26/0000004 Amended
Quality assurance EU MDR
- Issued
- 11 May 2026
- Expires
- 13 Jan 2031
- Reason
- Mnf ar change
Related companies
Notified bodies
- Notified body 1639
What LENTILLES makes
The company manufactures soft contact lenses designed for daily or extended wear, including models such as the PAUNELENS 3R and PAUNELENS 2R for general vision correction, as well as specialized variants like the XPR MC and EB AK-XPR for specific refractive needs or conditions. Additional variants, such as the EB OB-XPR, cater to particular optical prescriptions or patient requirements, ensuring a range of optical corrections for different eye care scenarios.
These devices are classified under EU Medical Device Regulation as Class IIa, indicating a moderate risk level requiring conformity assessment procedures. They are registered in the EU’s eudamed database, which tracks medical devices authorized for commercialization within the European Union. The company is based in France.
Frequently asked questions
What types of medical devices does LENTILLES manufacture?
LENTILLES manufactures soft contact lenses, including models like the PAUNELENS 3R and PAUNELENS 2R for general vision correction, as well as specialized variants such as the XPR MC and EB AK-XPR. These are designed for daily or extended wear, addressing specific refractive needs or conditions to provide tailored optical corrections for patients.
Where is LENTILLES based, and what does this mean for its regulatory oversight?
LENTILLES is based in France, which means its devices are subject to the European Union’s regulatory framework. Since these lenses are classified as Class IIa under the EU Medical Device Regulation, they undergo conformity assessment procedures to ensure safety and performance before being authorized for commercialization within the EU.
Which regulatory registries list LENTILLES’ devices, and why is this important?
LENTILLES’ devices are listed in the eudamed database, the EU’s official registry for medical devices authorized for sale within the European Union. This registration confirms that the devices comply with EU requirements and are legally available for distribution, ensuring transparency for healthcare providers and patients.
How are LENTILLES’ contact lenses classified under EU regulations, and what does this classification imply?
LENTILLES’ contact lenses are classified as Class IIa under the EU Medical Device Regulation. This classification indicates a moderate risk level, requiring additional scrutiny—such as technical documentation reviews and conformity assessments—to confirm their safety and performance before authorization. It ensures these devices meet stringent standards while balancing regulatory oversight with accessibility.
Information
- Country
- France
- Address
- 14, Place Gardin, CAEN, France
- Website
- www.laboratoire-lcs.com/
- [email protected]
- Phone
- +33231866656
- PRRC contact
- Hélène Blandureau
- EUDAMED SRN
- FR-MF-000006721