Needle Concept
FR-MF-000039283 · France · Biarritz
Needle Concept is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 45 |
|---|
Most frequent device types declared: U225 intradermal injector.
Among these devices, 43 are declared sterile, 2 reusable, 2 active.
Devices declared under this manufacturer
- HYPODERMIC NEEDLE
- MAGIC NEEDLE
- MESBIO Micro-injection kit
- U225 intradermal injector
Showing 12 of 45 declared devices.
Catalogue references include INM27G04, INM30G06, INM30G12, INM31G04, INM32G08, INM34G06.
European nomenclature codes declared: A0101010102, Z12040206.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 45 |
| 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 | 45 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NEEDLE CONCEPT |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2012-08-27 |
Licence types: Device Family (2), Single Device (1).
Licensed under: U225 INTRADERMAL INJECTOR, NEEDLE, KIT MESBIO - MICRO INJECTION KIT.
North American profile: Canada only. Needle Concept holds a Canadian licence but was not found in the U.S. register.