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OPTILAB S.R.L.

Italy IT-MF-000026824 Last updated 17 Sep 2026

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Devices
50
Registries
EUDAMED
FDA recalls
0

Catalogue50

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 0051 1 certificate

  • 066/MDR Issued

    Quality assurance EU MDR

    Issued
    21 Dec 2022
    Expires
    20 Dec 2027

Notified bodies

  • Notified body 0051

What OPTILAB S.R.L. makes

Optilab S.r.l. manufactures contact lenses, including spherical, toric, and multifocal designs made from hydrogel and silicone hydrogel materials. Examples include Bio Gel 55% Vari Vue, Bio-Sil BT XO, Bio Gel 54% Myopia Control, and Bio-Sil K2 XO, which are designed for vision correction and myopia management.

These devices are classified as Class IIa under the EU regulatory framework and are listed in the Eudamed database. The company is based in Italy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Optilab S.r.l. manufacture?

Optilab S.r.l. manufactures contact lenses, including spherical, toric, and multifocal designs made from hydrogel and silicone hydrogel materials, such as Bio Gel 55% Vari Vue, Bio-Sil BT XO, Bio Gel 54% Myopia Control, and Bio-Sil K2 XO, which are designed for vision correction and myopia management.

Where is Optilab S.r.l. based?

Optilab S.r.l. is based in Italy, as indicated by the country code IT in the provided data.

Which regulatory registry lists Optilab S.r.l.'s devices?

Optilab S.r.l.'s devices are listed in the Eudamed database, which is the European Union's medical device registry for tracking devices placed on the market under EU regulations.

How are Optilab S.r.l.'s devices classified under EU regulations?

Optilab S.r.l.'s devices are classified as Class IIa under the EU regulatory framework, which applies to medium-risk medical devices such as contact lenses that require conformity assessment but not the highest level of scrutiny.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Italy
Address
9, CORSO VINZAGLIO , TORINO, Italy
Website
optilab.eu
Phone
+39 011-544297
PRRC contact
LUCA XIMENES
EUDAMED SRN
IT-MF-000026824