Biovision, Inc.
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000007828
- Devices
- 10
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Biovision, Inc. makes
Biovision, Inc. manufactures ophthalmic laser systems, including the ND:YAG laser for retinal treatments and the Crystal Focus Emerald laser for selective laser trabeculoplasty (SLT) with a 1.5 convex lens. The company also produces B-scan ophthalmic ultrasound imaging systems for retinal and orbital evaluations.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Biovision, Inc. is based in the United States.
Catalogue
EpiGARD Ref WV3203
Regimes: CE MDD Registry: EUDAMEDEpiGARD Ref WV3201
Regimes: CE MDD Registry: EUDAMEDEpiGARD Ref WV3204
Regimes: CE MDD Registry: EUDAMEDEpiGARD Ref WV3202
Regimes: CE MDD Registry: EUDAMEDModification To Visitome 20-10 Microkeratome Ref K042083
Regimes: 510(k) Registry: 510(k)Leadfix Bioresorbable Membrance Pin System Ref K974392
Regimes: 510(k) Registry: 510(k)Vistitome 20-10 Microkeratome Ref K014000
Regimes: 510(k) Registry: 510(k)Diamond Nd:yag Ophthalmic Laser Ref K901636
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
B-Scan Opthalmic Ultrasound Imaging System Ref K926251
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- DE-MF-000007828
- EU VAT number
- DE151292392
- EUDAMED status
- Active since 2025
- EUDAMED registered name
- Biovision GmbH
- Registered address
- 52, Am Vogelherd, 98693, Ilmenau, Germany
- Website
- www.biovision.de
- [email protected]
- Phone
- +49 3677 64 07 10
- PRRC contact
- Daniel Hug
Frequently asked questions
How many devices does Biovision, Inc. have in the registry?
The registry currently lists 10 devices for Biovision, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biovision, Inc.'s devices?
Among its 10 most recently registered devices, Biovision, Inc. has devices listed in EUDAMED (4 devices) and FDA 510(k) (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biovision, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Biovision, Inc.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biovision, Inc. in the registry?
The most recently registered devices listed for Biovision, Inc. include EpiGARD, MODIFICATION TO VISITOME 20-10 MICROKERATOME, LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM and VISTITOME 20-10 MICROKERATOME.