Question 1

What types of medical devices does Oystershell NV manufacture?

Accepted Answer

Oystershell NV produces topical hair care and lice treatment products, including shampoos like *OWIX HAIR S.O.S SZAMPON*, anti-lice lotions such as *STOP PIOLHOS LOÇÃO – ANTI LUIS LOTION*, and scalp sprays like *ELIMAX EASY POWER LOTION SPRAY* and *ELIMAX ULTRA POWER SPRAY*. These products are designed for non-invasive scalp and hair applications, addressing issues like lice infestations and hair health.

Question 2

Where is Oystershell NV based, and what regulatory databases list its devices?

Accepted Answer

Oystershell NV is based in Belgium. Its devices are registered in the EU’s EUDAMED database under the EU Medical Device Regulation (MDR) framework, and they are also listed in the FDA’s 510(k) premarket notification process in the United States. This reflects compliance with both European and U.S. medical device regulations.

Question 3

How are Oystershell NV’s devices classified under EU regulations?

Accepted Answer

Oystershell NV’s devices are classified as Class I and Class IIa under the EU Medical Device Regulation (MDR). This classification is determined by their intended use—non-invasive topical applications for hair and scalp care, including lice treatment and hair-strengthening formulations. Class I devices are generally low-risk, while Class IIa includes products with a slightly higher risk profile, such as certain anti-lice treatments.

Question 4

Are Oystershell NV’s devices authorised for use in the United States?

Accepted Answer

Oystershell NV’s devices are listed under the FDA’s 510(k) premarket notification process, which means they have been evaluated for substantial equivalence to a legally marketed predicate device in the U.S. This process does not imply FDA approval for the company itself but confirms that individual devices meet regulatory requirements for marketing in the United States.

Question 5

What distinguishes Oystershell NV’s lice treatment products from other hair care items?

Accepted Answer

Oystershell NV’s lice treatment products, such as *STOP PIOLHOS LOÇÃO* and *NALOX EASY*, are specifically formulated as medical devices under EU and U.S. regulations due to their intended use in combating lice infestations. Unlike standard hair care products, these are classified as Class I or IIa devices because they directly address a health-related condition (pediculosis) rather than general hair maintenance. Other products like *OWIX HAIR S.O.S SZAMPON* focus on hair health but do not claim medical treatment for infestations.

Device	Model / Reference	Registries	Class	Status
Elimax Shampoo 250ml At	07010992	EUDAMED	Class I	Active
Endwarts Freeze	07011672	EUDAMED	Class IIa	Active
Label Elimax Pure Power Anti Laus Lösung 200ml	07030861	EUDAMED	Class I	Active
Label Elimax Shampoo 250ml Be	07030592	EUDAMED	Class I	Active
Label Elimax Pure Power 200ml Nl-Fr	07030862	EUDAMED	Class I	Active
Box Stop Piolhos Champô Tratamento 200ml	07011444	EUDAMED	Class I	Active
Apaisyl Anti-Poux Xpert Cire D’abeille	07030949	EUDAMED	Class I	Active
Elimax Natural Lotion	07030851	EUDAMED	Class I	Active
Excilor Easy Be Nl	07011525	EUDAMED	Class IIa	Active
Syylend Freeze Excel	07011678	EUDAMED	Class IIa	Active
Excilor Easy Pt	07011688	EUDAMED	Class IIa	Active
Hedrin Once Natural Lotion	07011523	EUDAMED	Class I	Active
Linicin Pluss Shampoo 250ml No	07011106	EUDAMED	Class I	Active
Box Elimax Šampoon/Šampūns/Šampūnas 100ml	07011720	EUDAMED	Class I	Active
Plastic Comb Blue No Logo With Udi	07080043	EUDAMED	Class I	Active
Excilor Easy Balt	07011629	EUDAMED	Class IIa	Active
Wortie Freeze Pro	07011754	EUDAMED	Class IIa	Active
Linicin Pluss Shampoo 250ml Dk	07010950	EUDAMED	Class I	Active
Label Elimax Šampoon/Šampūns/Šampūnas 100ml Est-Lat-Lit	07031058	EUDAMED	Class I	Active
Label Elimax Shampoo 100ml Hu	07031000	EUDAMED	Class I	Active
Box Parasidose Lotion 2en1 100ml	07011267	EUDAMED	Class I	Active
Label Linicin Plus Shampoo 100ml	07031059	EUDAMED	Class I	Active
Mosquito Med Shampoo 100ml	07010781	EUDAMED	Class I	Active
Linicin Pure Power 100ml No-Dk-Se	07011275	EUDAMED	Class I	Active
Stop Piolhos Champô Tratamento	07030897	EUDAMED	Class I	Active
Prioderm Anti-Luis Shampoo 100ml	07010822	EUDAMED	Class I	Active
Label Elimax Shampoo 100ml Cz-Sk	07030973	EUDAMED	Class I	Active
Linicin Pure Power 200ml Dk	07011276	EUDAMED	Class I	Active
Elimax Lotion 100ml Cz-Sk	07011626	EUDAMED	Class I	Active
Parasidose Shampoing 2en1 100ml Fr	07011266	EUDAMED	Class I	Active
Excilor Easy Uk	07011528	EUDAMED	Class IIa	Active
Elimax Lotion 100ml Hu	07030998	EUDAMED	Class I	Active
Endwarts Extra	07011687	EUDAMED	Class IIa	Active
Label Linicin Pluss Shampoo 250ml No	07030683	EUDAMED	Class I	Active
Linicin Plus Solution 250ml Dk	07011273	EUDAMED	Class I	Active
Box Apaisyl Anti-Poux Shampoing 3en1 200ml	07011740	EUDAMED	Class I	Active
Hedrin Once Natural Lotion	07011518	EUDAMED	Class I	Active
Wortie Krio Pro	07011759	EUDAMED	Class IIa	Active
Aftir Duo Lotion 100ml	07010870	EUDAMED	Class I	Active
Box Linicin Plus Shampoo 100ml	07011721	EUDAMED	Class I	Active
Excilor Easy Fr	07011524	EUDAMED	Class IIa	Active
Label Bevitamed Täishampoo 250ml	07030648	EUDAMED	Class I	Active
Label Bevitamed Täishampoo 100ml Fi	07030403	EUDAMED	Class I	Active
Syylend Skin Tags	07011685	EUDAMED	Class IIa	Active
Linicin Pluss Shampoo 100ml Dk	07010766	EUDAMED	Class I	Active
Apaisyl Anti-Poux Xpert Cire D’abeille	07030948	EUDAMED	Class I	Active
Label Elimax Shampoo 100ml Nl-Fr	07030469	EUDAMED	Class I	Active
Excilor Easy Ch	07011627	EUDAMED	Class IIa	Active
Box Apaisyl Anti-Poux Shampoing 3en1 100ml	07011739	EUDAMED	Class I	Active
Elimax Shampoo 100ml Fr-Nl	07010920	EUDAMED	Class I	Active

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