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FB VISION S.p.A.

Italy IT-MF-000020083 Last updated 17 Sep 2026

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Devices
28
Registries
EUDAMED
FDA recalls
0

Catalogue28

EUDAMED certificates2

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

EUDAMED certificates (2)

BUREAU VERITAS ITALIA S.P.A. 1370 1 certificate

  • IT328004 Issued

    Quality management system EU MDR

    Issued
    20 Dec 2023
    Expires
    19 Dec 2028

ICIM S.P.A. 0425 1 certificate

  • 0425-MDR-030111-00 Issued

    Quality management system EU MDR

    Issued
    19 Dec 2024
    Expires
    18 Dec 2029

Notified bodies

About

© Copyright 2026 FB VISION S.p.A. – VAT number 02259770440 – All rights reserved – Via San Giovanni Scafa – San Benedetto del Tronto – 63074 (AP)

Translated from the manufacturer's own website. Source

What FB VISION S.p.A. makes

FB Vision S.p.A. manufactures ophthalmic solutions, including intravenous and topical eye drops (e.g., Ozodrop IVT 15, Ozodrop 8 mL) and lubricating eye drops (e.g., Lacricomplex 10ml, LUMIXA 3 ml). The portfolio also includes sterile ophthalmic ointments (e.g., OPTICOL CROSSLIP 10 ml) and preservative-free formulations (e.g., AQUORAL LIPO 3ML MUESTRA). Some products are available in bilingual packaging (Italian and English).

These devices are classified under EU Medical Device Regulation as Class IIb, with all relevant products listed in the EUDAQD database (eudamed). The manufacturer 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 types of medical devices does FB Vision S.p.A. manufacture?

FB Vision S.p.A. specializes in ophthalmic medical devices, primarily eye care solutions. Their portfolio includes intravenous and topical eye drops (such as Ozodrop IVT 15 and Ozodrop 8 mL), lubricating eye drops (like Lacricomplex 10ml and LUMIXA 3 ml), and sterile ophthalmic ointments (e.g., OPTICOL CROSSLIP 10 ml). Some products are also available in preservative-free formulations, such as AQUORAL LIPO 3ML MUESTRA. These devices are designed for use in eye care applications.

Where is FB Vision S.p.A. based?

FB Vision S.p.A. is based in Italy, specifically in San Benedetto del Tronto, Ascoli Piceno (AP). The company’s headquarters is located at Via San Giovanni Scafa.

Which regulatory registries list FB Vision S.p.A.’s devices?

FB Vision S.p.A.’s devices are listed in the EUDAQD database (eudamed), which is the official European Union database for medical devices. This registry is used to track and provide transparency on medical devices authorized under the EU Medical Device Regulation.

How are FB Vision S.p.A.’s devices classified under EU regulations?

FB Vision S.p.A.’s devices are classified under the EU Medical Device Regulation as Class IIb. This classification is determined based on the risk associated with the device’s intended use and design. Class IIb devices require a higher level of scrutiny and conformity assessment compared to lower-risk classes, ensuring they meet stringent safety and performance standards.

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

Information

Country
Italy
Address
Snc, Via San Giovanni Scafa , San Benedetto del Tronto, Italy
Phone
+39 0736 230031
PRRC contact
Paolo Lategano
EUDAMED SRN
IT-MF-000020083