Emblation Limited
United KingdomFDA applicant, unverified FDA FEI 3015152398
Part of Emblation, Ltd.
- Devices
- 20
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Emblation Limited makes
Emblation Limited manufactures intraoperative gamma radiation detection system probe covers, microwave hyperthermia systems, and associated accessories. Their portfolio includes applicator tips for extracorporeal microwave hyperthermia, battery packs and chargers for noninvasive devices, and electrical power cables for medical systems. The company also produces secondary batteries and docking stations for portable medical equipment.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) and UDI pathways. Their products are intended for use in the United States, where regulatory compliance is required for market authorisation.
Catalogue
Search and filter all 20 devicesCompany details
- FDA FEI number
- 3015152398
- DUNS number
- 211334261
- Address
- 42 Albion Rd, Lincoln, RI, 02865
Frequently asked questions
How many devices does Emblation Limited have in the registry?
The registry currently lists 20 devices for Emblation Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Emblation Limited's devices?
Among its 20 most recently registered devices, Emblation Limited has devices listed in EUDAMED (2 devices), FDA 510(k) (2 devices) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Emblation Limited's devices fall under?
Among its 20 most recently registered devices, the classes recorded for Emblation Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Emblation Limited in the registry?
The most recently registered devices listed for Emblation Limited include Swiftips SWF-AT02-High, Swiftips SWF-AT02-Low, swiftPro Charging Dock DC Power Adaptor SWF-DCA02 and swiftPro System SWF-SPS01.