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Swift® Interconnect Cable SWF-CA01

by Emblation Limited

Ref SWF-CA01

Swift Interconnect Cable SWF-CA01 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 Limited, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI B-05060652910015), cleared under FDA 510(k) K181941 on 18 Oct 2018 and listed in FDA GUDID since 2 Jan 2019 (UDI-DI 05060652910015), active as of 23 Oct 2026.

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

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 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060652910015 Basic UDI-DI 05060652910015UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060652910015 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 B-05060652910015 registered 26 Jun 2026 Active
  • FDA 510(k) K181941 decided 18 Oct 2018 Active
  • FDA GUDID UDI-DI 05060652910015 listed 2 Jan 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181941
  2. Listed FDA GUDID 05060652910015
  3. Registered EUDAMED B-05060652910015

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Swift Connector Cable EUDAMED
Swift® Interconnect Cable GUDID
Generic name
Microwave hyperthermia system applicator, extracorporeal
Model / Ref / Catalog
SWF-CA01
Primary DI / UDI-DI
05060652910015
Basic UDI-DI
B-05060652910015
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
Legacy device (under a directive)
EU market of registration
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.

Related devices

Category: Microwave hyperthermia system applicator, extracorporeal

Cleared under the same submission (K181941)

Similar devices in this category

Other devices filed under MICROWAVE THERAPY EQUIPMENT.

Other devices from Emblation Limited

See all devices from Emblation Limited →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)