ZOVEC diagnostics GmbH
DE-MF-000035393 · Germany · Mannheim
ZOVEC diagnostics GmbH is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: DETERGENT, DILUENT, LYSE, PROBE CLEANER, Quality Control Kit.
Devices declared under this manufacturer
- DETERGENT
- DILUENT
- Daily Cleaners kit
- LYSE
- PROBE CLEANER
- Quality Control Kit
- Reference Solution
- Z-ELITE Li
- Z-GEM 3
- Z-GEM 5 Lyse 2
- Z-GEM 5 Lyse 3A
- Z-Hb Confirm
Showing 12 of 37 declared devices.
Catalogue references include Z-ELITE Li, Z-GEM 3, Z-RC5RP, Z-RDE5RP, Z-RDG3, Z-RL5RP.
European nomenclature codes declared: W0103010105, W0202010101, W0201040201, W0101050204, W01029003, W01019001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 37 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 37 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. ZOVEC diagnostics GmbH was not found in either the U.S. or the Canadian register.