Oystershell NV
Active in EUDAMEDBelgiumfrom SRN EUDAMED SRN BE-MF-000011797
- Devices
- 124
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Oystershell NV makes
Oystershell NV manufactures topical hair care and lice treatment products, including shampoos, lotions, and sprays designed to address hair health and infestations. Their portfolio includes formulations like anti-lice lotions, hair-strengthening shampoos, and power-spray treatments for scalp applications. Some products are also marketed as nit removal aids for lice treatment regimens.
The company’s devices fall under EU Medical Device Regulation (MDR) classifications of Class I and Class IIa, reflecting their intended use for non-invasive topical applications. These products are registered in the EU’s EUDAMED database and listed under the FDA’s 510(k) premarket notification process in the United States. The manufacturer is based in Belgium.
Catalogue
Search and filter all 124 devicesShowing 1-50 of 124
Company details
- EUDAMED SRN
- BE-MF-000011797
- SRN (system / procedure pack)
- BE-PR-000024807
- EU VAT number
- BE0419652979
- EUDAMED status
- Active
- EUDAMED registered name
- Oystershell NV
- Registered address
- 10, Nijverheidsweg, 9820, Merelbeke - Melle, Belgium
- Website
- www.oystershell.com
- Phone
- 0032.09.377.24.85
- PRRC contact
- Wouter Taghon
Frequently asked questions
How many devices does Oystershell NV have in the registry?
The registry currently lists 124 devices for Oystershell NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oystershell NV's devices?
Among its 50 most recently registered devices, Oystershell NV has devices listed in EUDAMED (49 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Oystershell NV's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Oystershell NV's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from Oystershell NV in the registry?
The most recently registered devices listed for Oystershell NV include ELIMAX ULTRA POWER SHAMPOO, ELIMAX ULTRA POWER LOTION, APAISYL® ANTI-POUX XPERT CIRE D’ABEILLE and APAISYL ANTI-POUX XPERT CIRE D´ABEILLE.