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HighSurg 30 3360

by Nouvag AG

Ref 3360

HighSurg 30 3360 is a device classified as Class IIa in the EU and Class II in the US made by Nouvag AG, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI B-+ENOU33600F), cleared under FDA 510(k) K042434 on 3 Nov 2004 and listed in FDA GUDID since 13 Jan 2017 (UDI-DI +ENOU33600F), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K042434

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/MDD EUDAMED NumberB-+ENOU33600F Basic UDI-DI +ENOU33600FUDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ENOU33600F UDI-DI Date13 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042434 Date3 Nov 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+ENOU33600F registered 6 Jul 2026 Active
  • FDA 510(k) K042434 decided 3 Nov 2004 Active
  • FDA GUDID UDI-DI +ENOU33600F listed 13 Jan 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K042434
  2. Listed FDA GUDID +ENOU33600F
  3. Registered EUDAMED B-+ENOU33600F

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  • Withdrawn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
HighSurg 30
Generic name
Surgical power tool system control unit, line-powered
Model / reference
3360
Primary DI / UDI-DI
+ENOU33600F EUDAMED
ENOU33600 GUDID
Basic UDI-DI
B-+ENOU33600F
510(k) Number
FDA product code
HBC, ERL
EMDN code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN term
Surgical power tool system control unit, line-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4360, 874.4250
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+ENOU33600F
GUDID
ENOU33600
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists +ENOU33600F; FDA GUDID lists ENOU33600), 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 power tool system control unit, line-powered

Cleared under the same submission (K042434)

and 8 more cleared under K042434

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER.

Other devices from Nouvag AG

See all devices from Nouvag AG →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)