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
Catalogue
Ozolid 20 garze Ref 938833744
Ozolid 2 garze Ref 938833744/CAMP
Ozolid 20 BG Ref 10521740BG
Ozonest 2 Toallitas PT Ref 00741740PT
Desodrop Ref 00241720CZSKSI
Ozodrop Ref 939278901/CAMP
Ozonest 20 Toallitas ES Ref 10141740ES
Ozolid 20 PLHU Ref 10531740PLHU
Ozonest 20 Toalhitas PT Ref 10731740PT
Ozonest 2 Toallitas ES Ref 00161740ES
Ozodrop IVT 15 Ref 10581750IT
Ozodrop 8 mL Ref 10551720IT
OPTICOL CROSSLIP 10 ml Ref 10681700PT
Aquoral Lipo 3ml Muestra Ref 00671700ES
Ozodrop IVT 15 - ENG Ref 10601750ENG
Lacricomplex 10ml Ref 10051710IT
Lacricomplex 10ml – ENG Ref 10321710GB
Ozodrop 8 mL - ENG Ref 10571720ENG
LUMIXA Flacone da 10 ml Ref 10631700IT
OPTICOL CROSSLIP AMOSTRA 3 ml Ref 00691700PT
LUMIXA adv 10 ml Ref 10651700PK
LUMIXA 3 ml / CAMP Ref 00641700IT
Ozodrop 3 mL Ref 00561720IT
AQUORAL LIPO 10 ml Ref 10661700ES
LUMIXA 10 ml Ref 10611700RUUZ
PROLUXX Lipo X - 10 ml Ref 10541700HRSI
LUMIXA 10 ml Ref 10621700BGTRRUAZ
Lacricomplex 3ml Ref 00041700IT
Lacricomplex 10ml Ref 10031700IT
LUMIXA 10 ml Ref 10371700GB
PROLUXX Lipo X - 10 ml Ref 10701700BARS
Ozodrop IVT 5 Ref 00591750IT
EUDAMED certificates
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
Related companies
Notified bodies
- ICIM S.P.A. 0425
- BUREAU VERITAS ITALIA S.P.A. 1370
About
© Copyright 2026 FB VISION S.p.A. – VAT number 02259770440 – All rights reserved – Via San Giovanni Scafa – San Benedetto del Tronto – 63074 (AP)
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.
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.
Information
- Country
- Italy
- Address
- Snc, Via San Giovanni Scafa , San Benedetto del Tronto, Italy
- Website
- www.fb-vision.it
- [email protected]
- Phone
- +39 0736 230031
- PRRC contact
- Paolo Lategano
- EUDAMED SRN
- IT-MF-000020083