# Emblation, Ltd.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Emblation, Ltd. is a medical device manufacturer based in the United Kingdom, with 6 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I and IIb; FDA Class II) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/emblation-ltd>
- Also registered as: EMBLATION LIMITED
- Country: United Kingdom (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: GB-MF-000021381

## Figures

- Devices: 6
- FDA recalls (matched to the firm by name): 0
- FDA establishments: 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 4, FDA GUDID 4, FDA 510(k) 2
- Device classes: EU Class I 2, EU Class IIb 2, FDA Class II 2
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 4 devices

## Sites and related companies

- Authorised representative: [Emergo Europe B.V.](https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116) (Netherlands)

## Devices

The first 6 of 6, in the order of the canonical page, which lists them all.

- [swiftPro System](https://devicerts.com/devices/swiftpro-system-ney) · ref K222388 · Class II · 510(k) · status: Active · decision 2023-05-04
- [Swift System](https://devicerts.com/devices/swift-system-ney) · ref K181941 · Class II · 510(k) · status: Active · decision 2018-10-18
- [Swift®](https://devicerts.com/devices/swift-r-swf-hp01) · ref SWF-HP01 · Class IIb · EUDAMED, GUDID · status: Active
- [Swift®](https://devicerts.com/devices/swift-r-swf-at01-10) · ref SWF-AT01-10 · Class I · EUDAMED, GUDID · status: Active
- [Swift®](https://devicerts.com/devices/swift-r-swf-ge01) · ref SWF-GE01 · Class IIb · EUDAMED, GUDID · status: Active
- [Swift®](https://devicerts.com/devices/swift-r-swf-at01) · ref SWF-AT01 · Class I · EUDAMED, GUDID · status: Active

## Source and citation

- Cite as: Emblation, Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/emblation-ltd (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/emblation-ltd.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/emblation-ltd
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.