POLYFLAME EUROPE SAS
FR-MF-000042860 · France · CROISSY BEAUBOURG
POLYFLAME EUROPE SAS is registered in the European database on medical devices as a manufacturer, with 424 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 424 |
|---|
Most frequent device types declared: BL-037-G, FL-CB, JD-AB-009, KC939315, KC990625.
Devices declared under this manufacturer
- CH READING GLASSE W/HANDTAG DIO1.5
- CH VISION READING GLASSES DIO 2.0
- CH VISION READING GLASSES DIO 2.5
- CH VISION READING GLASSES DIO 3.0
- CHAMP HEALTH - DINO BAND AIDS BLIST.10 P
- CHVISION READING GLASSES 2026 DIO.2.5-D24
- CHVISION READING GLASSES 2026 DIO.3.5
- CHVISION READING GLASSES 2026 DIO1.5-D24
- HK CINNA GLITTER BANDAIDS METAL BOX
- HK FRIENDS SET 20 PIMPLE PATCH AA ASS-24
- TAKE CARE EYEWEAR CAMILLE BROWN & TORT. DIO +2.0
- TAKE CARE EYEWEAR CHARLIE - DIOPTER +1.0
Showing 12 of 424 declared devices.
Catalogue references include 40448750, 40448774 (PR-P15802), 40448847 [KC990625L], 40448849 [KC939315A], 40448851 [KCR24065L], 40509396.
European nomenclature codes declared: Q0210030102, M03030202, Q0210030101, V9099, M0599, Q0210030103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 424 |
| 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 | 424 |
|---|---|
| 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. POLYFLAME EUROPE SAS was not found in either the U.S. or the Canadian register.