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Curaway CNP-III

by Zhejiang CuraWay Medical Technology Co., Ltd.

Ref CNP-III

Curaway CNP-III is an irreversible electroporation system (EU MDR Class IIb; FDA Class II; FDA product code OAB, Low Energy Direct Current Thermal Ablation System) made by Zhejiang CuraWay Medical Technology Co., Ltd., registered in EUDAMED on 13 Nov 2025 (Basic UDI-DI 69366665NKSF2X), cleared under FDA 510(k) K222001 on 8 Jun 2023 and listed in FDA GUDID since 11 Aug 2025 (UDI-DI 06936666508908), 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) K222001

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69366665NKSF2X Basic UDI-DI 06936666508908UDI-DIDate13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06936666508908 UDI-DI Date11 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222001 Date8 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69366665NKSF2X registered 13 Nov 2025 Active
  • FDA 510(k) K222001 decided 8 Jun 2023 Active
  • FDA GUDID UDI-DI 06936666508908 listed 11 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222001
  2. Listed FDA GUDID 06936666508908
  3. Registered EUDAMED 69366665NKSF2X

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  • Withdrawn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

Trade name
Curaway
Generic name
Irreversible electroporation system
Model / reference
CNP-III
Primary DI / UDI-DI
06936666508908 EUDAMED
06936666557944 GUDID
Basic UDI-DI
69366665NKSF2X
510(k) Number
FDA product code
OAB
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Irreversible electroporation 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 · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06936666508908
GUDID
06936666557944
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06936666508908; FDA GUDID lists 06936666557944), so their flags are not compared. 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: Irreversible electroporation system

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Zhejiang CuraWay Medical Technology Co., Ltd.

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Properties

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