Eyeyon Medical
Active in EUDAMEDIsraelfrom SRN EUDAMED SRN IL-MF-000016053
Part of EyeYon Medical Ltd.
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What Eyeyon Medical makes
Eyeyon Medical manufactures hydrophilic soft contact lenses designed for daily wear, including standard daily-use lenses and therapeutic variants. The portfolio includes hioxiricon D-based contact lenses for extended comfort and vision correction.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- 510(k) 510(k)
Hyper-CL Ref KIT-003-EU
CE MDD EUDAMED
Company details
- EUDAMED SRN
- IL-MF-000016053
- EU VAT number
- DE362473568
- EUDAMED status
- Active
- EUDAMED registered name
- EyeYon Medical Ltd.
- EUDAMED abbreviated name
- EyeYon
- Registered address
- 3. Golda Meir St., Ness Ziona 7403648, Israel, 7403648, Ness Ziona, Israel
- Website
- www.eye-yon.com
- [email protected]
- Phone
- +972737803607
- PRRC contact
- Hagit Rudich Wilf
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 6 May 2028
Notified body 0482 2 certificates
- 20506GB450240808 Issued
Technical documentation EU MDR
- Issued
- 8 Aug 2024
- Expires
- 7 Aug 2029
- 7406GB448240808 Issued
Quality management system EU MDR
- Issued
- 8 Aug 2024
- Expires
- 6 May 2028
Frequently asked questions
How many devices does Eyeyon Medical have in the registry?
The registry currently lists 2 devices for Eyeyon Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eyeyon Medical's devices?
Among its 2 most recently registered devices, Eyeyon Medical has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Eyeyon Medical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eyeyon Medical's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Eyeyon Medical?
EUDAMED lists 2 certificates for Eyeyon Medical (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2024-08-08.
What are the newest devices from Eyeyon Medical in the registry?
The most recently registered devices listed for Eyeyon Medical include EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear and Hyper-CL.