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Microwave Ablation Generator

by Canyon Medical Inc. 2 variants

Ref KY-2100A

Microwave Ablation Generator (KY-2100A) is a microwave hyperthermia system (EU MDR Class IIb; FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Canyon Medical Inc., registered in EUDAMED on 15 Nov 2024 (Basic UDI-DI 6954414600100003EH), cleared under FDA 510(k) K241827 on 26 Sep 2024 and listed in FDA GUDID since 14 Mar 2025 (UDI-DI 06954414674453), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241827

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06954414674453 UDI-DI Date14 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6954414600100003EH Basic UDI-DI 06954414674453UDI-DIDate15 Nov 2024RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK241827 Date26 Sep 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6954414600100003EH registered 15 Nov 2024 Active
  • FDA 510(k) K241827 decided 26 Sep 2024 Active
  • FDA GUDID UDI-DI 06954414674453 listed 14 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241827
  2. Registered EUDAMED 6954414600100003EH
  3. Listed FDA GUDID 06954414674453

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Microwave hyperthermia system
Model / reference
KY-2100A
Primary DI / UDI-DI
06954414674453
Basic UDI-DI
6954414600100003EH
Direct marketing DI
06954414674453
510(k) Number
FDA product code
NEY
EMDN code
Z120608 Microwave therapy equipment
GMDN term
Microwave hyperthermia system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
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.

Manufacturer details

EUDAMED SRN
CN-MF-000022663
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Microwave ablation system probe, non-powered

Similar devices in this category

Other devices filed under MICROWAVE THERAPY EQUIPMENT.

Other devices from Canyon Medical Inc.

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Properties

  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)