Skip to content

Vacuson 60 4280-115

by Nouvag AG

Ref 4280-115Model Flow rate 70l/min, 115 Volt

Vacuson 60 4280-115 is a device classified as Class IIa in the EU and Class II in the US made by Nouvag AG, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-+ENOU42801150O), cleared under FDA 510(k) K042943 on 17 Dec 2004 and listed in FDA GUDID since 13 Jan 2017 (UDI-DI +ENOU42801150O), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K042943

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+ENOU42801150O Basic UDI-DI +ENOU42801150OUDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ENOU42801150O UDI-DI Date13 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042943 Date17 Dec 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+ENOU42801150O registered 20 Oct 2026 Active
  • FDA 510(k) K042943 decided 17 Dec 2004 Active
  • FDA GUDID UDI-DI +ENOU42801150O listed 13 Jan 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K042943
  2. Listed FDA GUDID +ENOU42801150O
  3. Registered EUDAMED B-+ENOU42801150O

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Vacuson 60
Generic name
Surgical suction pump
Model / reference
4280-115, Flow rate 70l/min, 115 Volt
Primary DI / UDI-DI
+ENOU42801150O EUDAMED
ENOU42801150 GUDID
Basic UDI-DI
B-+ENOU42801150O
510(k) Number
FDA product code
BTA
EMDN code
Z120105 Surgical medical aspirators
GMDN term
Surgical suction pump
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+ENOU42801150O
GUDID
ENOU42801150
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +ENOU42801150O; FDA GUDID lists ENOU42801150), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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 suction pump

Cleared under the same submission (K042943)

Similar devices in this category

Other devices filed under SURGICAL MEDICAL ASPIRATORS.

Other devices from Nouvag AG

See all devices from Nouvag AG →

Properties

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