Skip to content

CNERGY Go!

by Cablon Medical B.V.

Ref C01-09, C01-09-03

CNERGY Go! (C01-09) is a device classified as Class I in the EU and Class II in the US made by Cablon Medical B.V., registered in EUDAMED on 19 Sep 2022 (Basic UDI-DI 87179530040C01-09QV), cleared under FDA 510(k) K960510 on 22 Apr 1996 and listed in FDA GUDID since 11 Nov 2024 (UDI-DI 08717953004048), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K960510

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08717953004048 UDI-DI Date11 Nov 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number87179530040C01-09QV Basic UDI-DI Date19 Sep 2022RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK960510 Date22 Apr 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 87179530040C01-09QV registered 19 Sep 2022 Active
  • FDA 510(k) K960510 decided 22 Apr 1996 Active
  • FDA GUDID UDI-DI 08717953004048 listed 11 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K960510
  2. Registered EUDAMED 87179530040C01-09QV
  3. Listed FDA GUDID 08717953004048

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  • Withdrawn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
CNERGY Go! EUDAMED
CNERGY Go! Portable Hand Scanner EUDAMED
PIM Portable Hand Palm Scanner GUDID
PIM Fixed Hand Palm Scanner GUDID
Generic name
Radiation therapy treatment record/verify system
Model / Ref / Catalog
C01-09, C01-09-03, C01-09-02
Primary DI / UDI-DI
08717953004048, 87179530040554, 87179530040486
Basic UDI-DI
87179530040C01-09QV
Direct marketing DI
87179530040554
510(k) Number
FDA product code
IYE
EMDN code
Z11010180, V9099
GMDN term
Radiation therapy treatment record/verify system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Netherlands
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
NL-MF-000002582

Related devices

Category: Accelerator system quality assurance device

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS - HARDWARE ACCESSORIES.

Other devices from Cablon Medical B.V.

Properties

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