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Qevo Ecu 7213

by Carl Zeiss Meditec AG

Ref 7213

Qevo Ecu 7213 is a device classified as Class I in the EU and Class II in the US made by Carl Zeiss Meditec AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 4049539_0_7213_T7), cleared under FDA 510(k) K232159 on 21 Sep 2023 (1 earlier submission) and listed in FDA GUDID since 24 Aug 2017 (UDI-DI 04049539072139), 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) K232159

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049539_0_7213_T7 Basic UDI-DI 04049539072139UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK232159 Date21 Sep 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04049539072139 UDI-DI Date24 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4049539_0_7213_T7 registered 23 Jul 2026 Active
  • FDA 510(k) K232159 decided 21 Sep 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04049539072139 listed 24 Aug 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K170667
  2. Listed FDA GUDID 04049539072139
  3. Cleared FDA 510(k) K232159
  4. Registered EUDAMED 4049539_0_7213_T7

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  • Withdrawn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
Qevo Ecu
Generic name
Endoscopic video image processing unit
Device name
Endocopic Control Unit
Model / reference
7213
Primary DI / UDI-DI
04049539072139
Basic UDI-DI
4049539_0_7213_T7
Direct marketing DI
04049539072139
510(k) Number
FDA product code
GWG
EMDN code
Z12020902 Neuroscopes
GMDN term
Endoscopic video image processing unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1480
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 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: Endoscopic video imaging system

Cleared under the same submission (K170667)

Cleared under the same submission (K232159)

Similar devices in this category

Other devices filed under NEUROSCOPES.

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)