Halotech DNA
ES-MF-000001921 · Spain · Madrid
Halotech DNA is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- dyn-halosperm
- halosperm
- halosperm G2
- halosperm G2 PRO
- ovoselect
- oxiSperm II
Catalogue references include HT-DHS5G2, HT-HS10, HT-HSG2, HT-HSG2P, HT-OS20II, HT-OVS10.
European nomenclature codes declared: W01019099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HALOTECH DNA (ES) · FDA 3008650534 |
| Devices in EUDAMED | 6 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| 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: United States only. Halotech DNA is registered in the United States but was not found in the Canadian register.