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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Optikon 2000 S.p.A. — Manufacturer in Italy

MD Atlas update: May 30, 2026

Optikon 2000 S.p.A.

IT-MF-000017618

Active

Address: via del Casale di Settebagni, 13 00138 Roma
Role: Manufacturer
Date of registration: Dec 2, 2021
Country: IT Italy

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Device families (Basic UDI-DI) of Optikon 2000

Showing 1–12 of 12 device families.

New Phaco Tips Wrench8059308SUR_ACC_028JT
EasySys cassette kit8059308SUR_IAC_021MT
22G flared phaco tip, 30°8059308SUR_TIP_0263S
PHACO HANDPIECE "SIX"8059308SUR_HPC_025TM
R-Evolution/R-Evo smart drapes8059308EQ_COV_024HN
19G VISCOUS FLUID REMOVAL KIT8059308SUR_INF_016UC
Adapter syringe tubing LLF8059308SUR_ACC_019JS
I/A kit for Pulsar II MS: cassette, drainage bag8059308SUR_TBS_008ZT
I/A tubing set for Pulsar II MS8059308SUR_TBS_007ZR
CRYO PROBE FOR GLAUCOMA8059308EQ_CRP_033GU
R-EVOLUTION CR WITH ENDOLASER8059308EQ_REV_005MF
R-EVO SMART CR8059308EQ_SMR_004PS

Certificate health for Optikon 2000

No certificates registered for this manufacturer.

Statistics for Optikon 2000

182Total Devices

23Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Market presence of Optikon 2000

Devices placed in 1 country

Italy182

Devices by risk class

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About Optikon 2000

SRN: IT-MF-000017618
Role: Manufacturer
Country: Italy
Organization name: Optikon 2000 S.p.A.
EU VAT number: 04678121007
EORI: IT04678121007
Trade register: 04678121007 CCIAA 792919
Date of registration: Dec 2, 2021

Contact details for Optikon 2000

Address: 13, VIA DEL CASALE DI SETTEBAGNI 00138 ROMA ITALY
Phone: +39 06 8888410
Email: mronchetti@bvimedical.com
Website: www.optikon.com

Validator

Name: Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico
SRN: IT-CA-070
Phone: +39 06 5994 3199/ +39 06 5994 3207
Email: segr.dgfdm@sanita.it

Officers and regulatory representatives of Optikon 2000

RONCHETTI Mattia
Assicurare che: a) la conformità dei dm sia adeguatamente controllata conformemente al SGQ prima del rilascio b) la documentazione tecnica e la dichiarazione di conformità UE siano redatte e aggiornate c) siano soddisfatti gli obblighi di sorveglianza post-commercializzazione di cui all'articolo 10, paragrafo 10 d) siano soddisfatti gli obblighi di segnalazione di cui agli articoli da 87 a 91 e) per i dm oggetto di indagine sia rilasciata la dichiarazione di cui all'all. XV, capo II, punto 4.1.
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Device catalog for Optikon 2000

No devices registered for this manufacturer.