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Acu-Evac Evac Ie-2

by Acuderm, Inc.

Ref EVAC IE-2Model ACU-EVAC

Acu-Evac Evac Ie-2 is a device classified as Class I in the EU and Class II in the US made by Acuderm, Inc., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 081410502ACUEVACXF), cleared under FDA 510(k) K930043 on 9 Feb 1994 and listed in FDA GUDID since 3 Jan 2020 (UDI-DI 10814105020446), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K930043

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/MDR EUDAMED Number081410502ACUEVACXF Basic UDI-DI 10814105020446UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10814105020446 UDI-DI Date3 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK930043 Date9 Feb 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081410502ACUEVACXF registered 2 Oct 2026 Active
  • FDA 510(k) K930043 decided 9 Feb 1994 Active
  • FDA GUDID UDI-DI 10814105020446 listed 3 Jan 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K930043
  2. Listed FDA GUDID 10814105020446
  3. Registered EUDAMED 081410502ACUEVACXF

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  • Withdrawn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
Acu-Evac
Generic name
Surgical plume evacuation system
Model / reference
EVAC IE-2, ACU-EVAC
Primary DI / UDI-DI
10814105020446
Basic UDI-DI
081410502ACUEVACXF
Direct marketing DI
10814105020446
510(k) Number
FDA product code
FYD
EMDN code
Z12019004 Surgical smoke evacuation systems
GMDN term
Surgical plume evacuation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.5070
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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.

Related devices

Category: Surgical plume evacuation system

Cleared under the same submission (K930043)

and 8 more cleared under K930043

Similar devices in this category

Other devices filed under SURGICAL SMOKE EVACUATION SYSTEMS.

Other devices from Acuderm, Inc.

  • Acu-Evac Adpack

    Class II

  • Acu-Evac ARMC1

    Class II

  • Acu-Evac Adlpack

    Class II

  • Acu-Punch

    Class IIa

See all devices from Acuderm, Inc. →

Properties

  • Serial number
Other properties (24, all answered No)