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Convivo 6918

by Carl Zeiss Meditec AG

Ref 6918

Convivo 6918 is a scanning laser optical microscope (EU MDR Class IIa; FDA Class II) made by Carl Zeiss Meditec AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 4049539_0_6918_UU) with CE/MDR certificate 1000335292 valid until 5 Jan 2027, cleared under FDA 510(k) K211156 on 29 Dec 2021 (1 earlier submission) and listed in FDA GUDID since 13 Dec 2019 (UDI-DI 04049539069184), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

5 Jan 2027

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

510(k) K211156

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000335292 Date16 Sep 2026IssuedStatusExpiring expires 5 Jan 2027
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211156 Date29 Dec 2021DecidedStatusActive
United StatesGUDID listing GUDID Number04049539069184 UDI-DI Date13 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4049539_0_6918_UU registered 23 Jul 2026 Active· +1 more in the status table
  • FDA 510(k) K211156 decided 29 Dec 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04049539069184 listed 13 Dec 2019 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000335292 Expiring Supplemented Expires in 52 days

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    16 Sep 2026
    Expires
    5 Jan 2027
    Reason
    Add device or group
  • 1000335292 Expiring Supplemented Expires in 52 days Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    16 Sep 2026
    Expires
    5 Jan 2027
    Reason
    Change approved

Timeline

6 dated events

  1. Cleared FDA 510(k) K181116
  2. Listed FDA GUDID 04049539069184
  3. Cleared FDA 510(k) K211156
  4. Registered EUDAMED 4049539_0_6918_UU
  5. Certificate issued EUDAMED 1000335292
  6. Certificate expires EUDAMED 1000335292

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Convivo
Generic name
Scanning laser optical microscope
Device name
Confocal Endomicroscopy System
Model / reference
6918
Primary DI / UDI-DI
04049539069184
Basic UDI-DI
4049539_0_6918_UU
Direct marketing DI
04049539069184
510(k) Number
FDA product code
LLZ, OWN, GWG
EMDN code
Z12011199 Instruments for operative microscopy – other
GMDN term
Scanning laser optical microscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050, 876.1500, 882.1480
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Scanning laser optical microscope

Cleared under the same submission (K181116)

Cleared under the same submission (K211156)

Similar devices in this category

Other devices filed under INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER.

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

  • Prescription use
  • Combination product
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)