BIOLABO
FR-MF-000001633 · France · Maizy
BIOLABO is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: BIO SOLEA 2.
Devices declared under this manufacturer
- BIO SOLEA 2 - COAGULOMETER 2 CHANNELS, including accessories
- BIO SOLEA 4 - COAGULOMETER 4 CHANNELS, including accessories
- Cleaning Solution for TIA
- EXTRA Cleaning
- IPO Cleaning
- KENZA 240ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, includ
- KENZA 450ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, includ
- KENZA 450TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories
- KENZA MAX BioChemisTry PHOTOMETER
- KENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories
- NaOH Solution 0.4 N
- OWREN KOLLER BUFFER
Showing 12 of 20 declared devices.
Catalogue references include 92026, BIOSOLEA 2, CO0058, CO4000, KENZA 450TX, KENZA MAX.
European nomenclature codes declared: W0103010105, W0201010101, W0202020101, W0103020903, W01019001, W0201010102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 20 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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. BIOLABO was not found in either the U.S. or the Canadian register.