# Convivo 6918

> Expiring: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/convivo-6918>
- Manufacturer: [Carl Zeiss Meditec AG](https://devicerts.com/manufacturers/carl-zeiss-meditec-ag) (Germany)
- Name in the registry: CONVIVO 6918
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: LLZ, OWN, GWG
- EMDN: Z12011199 INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER
- GMDN: Scanning laser optical microscope (36225)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · 1000335292 · issued 2026-09-16 · expires 2027-01-05 · status: Expiring
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 4049539\_0\_6918\_UU · UDI-DI 04049539069184 · registered 2026-07-23 · status: Active
- **GUDID** · FDA 510(k) · United States · K211156 · decision 2021-12-29 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 04049539069184 · listed 2019-12-13 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K181116 · decision 2018-10-25 · decision SESE · status: Active · from GUDID

## EU certificates

- 1000335292 · Quality management system · MDR · notified body DQS Medizinprodukte GmbH · issued 2026-09-16 · expires 2027-01-05 · status: supplemented
- 1000335292 · Quality management system · MDR · notified body DQS Medizinprodukte GmbH · issued 2026-09-16 · expires 2027-01-05 · status: supplemented (no longer listed by EUDAMED)

## Recalls

No recall on record.

## Identity

- Trade name: CONVIVO [FDA GUDID (AccessGUDID)]
- Generic name: Scanning laser optical microscope [FDA GUDID (AccessGUDID)]
- Device name: Confocal Endomicroscopy System [EUDAMED]
- Model / reference: 6918 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04049539069184 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 4049539\_0\_6918\_UU [EUDAMED]
- Direct marketing DI: 04049539069184 [EUDAMED]
- 510(k) Number: K181116 [FDA GUDID (AccessGUDID)]; K211156 [FDA GUDID (AccessGUDID)]
- FDA product code: LLZ [FDA GUDID (AccessGUDID)]; OWN [FDA GUDID (AccessGUDID)]; GWG [FDA GUDID (AccessGUDID)]
- EMDN code: Z12011199 [EUDAMED]
- GMDN term: Scanning laser optical microscope (36225) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.2050 [FDA GUDID (AccessGUDID)]; 876.1500 [FDA GUDID (AccessGUDID)]; 882.1480 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Combination product: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Convivo 6918, Carl Zeiss Meditec AG. deviCERTS medical device catalogue. https://devicerts.com/devices/convivo-6918 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/convivo-6918.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/convivo-6918
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.