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Endovapor® REFUSS01

by Joimax GmbH

Ref REFUSS01

Endovapor® REFUSS01 is a device classified as Class IIb in the EU and Class II in the US made by Joimax GmbH, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 42503371FUSSENDMZ), cleared under FDA 510(k) K170358 on 21 Apr 2017 and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 04250337108405), active as of 12 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170358

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371FUSSENDMZ Basic UDI-DI 04250337108405UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337108405 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170358 Date21 Apr 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 42503371FUSSENDMZ registered 22 May 2026 Active
  • FDA 510(k) K170358 decided 21 Apr 2017 Active
  • FDA GUDID UDI-DI 04250337108405 listed 30 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170358
  2. Listed FDA GUDID 04250337108405
  3. Registered EUDAMED 42503371FUSSENDMZ

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  • Withdrawn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
Foot Switch joimax® Endovapor®2 EUDAMED
Endovapor® GUDID
Generic name
Foot-switch, electrical
Model / Ref / Catalog
REFUSS01
Primary DI / UDI-DI
04250337108405
Basic UDI-DI
42503371FUSSENDMZ
Direct marketing DI
04250337108405
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Foot-switch, electrical
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.

Related devices

Category: Foot-switch, electrical

Cleared under the same submission (K170358)

and 8 more cleared under K170358

Similar devices in this category

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

Other devices from Joimax GmbH

See all devices from Joimax GmbH →

Properties

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