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Swift®

by Emblation Ltd 2 variants

Ref SWF-HP01Model Swift® Applicator Handpiece

Swift (SWF-HP01) is a microwave hyperthermia system applicator (EU MDD Class IIb; FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Emblation, Ltd., registered in EUDAMED on 30 Aug 2022 (Basic UDI-DI 5060652910022TV), cleared under FDA 510(k) K181941 on 18 Oct 2018 and listed in FDA GUDID since 2 Jan 2019 (UDI-DI 05060652910022), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181941

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number5060652910022TV Basic UDI-DI 05060652910022UDI-DIDate30 Aug 2022RegisteredStatusActive
European UnionCE/MDR EUDAMED Number5060652910022TV Basic UDI-DI 05060652910022UDI-DIDate30 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05060652910022 UDI-DI Date2 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181941 Date18 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5060652910022TV registered 30 Aug 2022 Active· +1 more in the status table
  • FDA 510(k) K181941 decided 18 Oct 2018 Active
  • FDA GUDID UDI-DI 05060652910022 listed 2 Jan 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181941
  2. Listed FDA GUDID 05060652910022
  3. Registered EUDAMED 5060652910022TV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Swift® EUDAMED
Swift Handpiece EUDAMED
Swift Applicator Handpiece GUDID
Generic name
Microwave hyperthermia system applicator, extracorporeal
Model / Ref / Catalog
Swift® Applicator Handpiece, SWF-HP01
Primary DI / UDI-DI
05060652910022
Basic UDI-DI
5060652910022TV, B-05060652910022
FDA product code
NEY
EMDN code
Z120608 Microwave therapy equipment
GMDN term
Microwave hyperthermia system applicator, extracorporeal
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Northern Ireland
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
GB-MF-000021381
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Microwave ablation system probe, non-powered

Similar devices in this category

Other devices filed under MICROWAVE THERAPY EQUIPMENT.

Other devices from Emblation, Ltd.

  • swiftPro System

    Class II

  • Swift System

    Class II

  • Swift®

    Class I

  • Swift®

    Class IIb

See all devices from Emblation, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)