Surgease Innovations Limited
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000016541
- Devices
- 17
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Surgease Innovations Limited makes
Surgease Innovations Limited manufactures the LumenEye® X1 endoscope, a reusable medical device designed for internal imaging procedures, along with its associated single-use consumables and pre-packaged sets. These consumables include disposable components required for maintenance and operation of the endoscope, ensuring sterile and reusable imaging capabilities.
The company’s portfolio is regulated under FDA Class II devices, with authorisation supported by 510(k) clearances. The devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 17 devicesCompany details
- EUDAMED SRN
- GB-MF-000016541
- DUNS number
- 221628713
- EU VAT number
- GB 302 514 650
- EUDAMED status
- Active
- EUDAMED registered name
- SurgEase Innovations Ltd.
- Registered address
- Burlington House, 1-13 York Road, SL6 1SQ, Berkshire, United Kingdom (ex Northern Ireland)
- Website
- www.surgease.com
- [email protected]
- Phone
- +44 (0) 330 043 6989
- PRRC contact
- Fareed Iqbal
FDA establishments
- Surgease Innovations Ltd Berkshire England · GB FEI 3038293255
Frequently asked questions
How many devices does Surgease Innovations Limited have in the registry?
The registry currently lists 17 devices for Surgease Innovations Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgease Innovations Limited's devices?
Among its 17 most recently registered devices, Surgease Innovations Limited has devices listed in EUDAMED (15 devices), FDA 510(k) (1 device) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Surgease Innovations Limited's devices fall under?
Among its 17 most recently registered devices, the classes recorded for Surgease Innovations Limited's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgease Innovations Limited in the registry?
The most recently registered devices listed for Surgease Innovations Limited include TriEye System, TriEye, LumenEye X1 System and LumenEye X1.
Which FDA establishments are linked to Surgease Innovations Limited?
1 FDA establishment is linked to Surgease Innovations Limited in the registry; they are listed on the company page.