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 Easy Power Lotion Spray	07031094	EUDAMED	Class I	Active
Elimax Ultra Power Spray	07031121	EUDAMED	Class I	Active
Nalox Easy	07011760	EUDAMED	Class IIa	Active
Owix Hair S.o.s Szampon	07011774	EUDAMED	Class I	Active
Stop Piolhos Loção – Anti Luis Lotion	07011722	EUDAMED	Class I	Active
Pixie NO2, Pixie NO2 XL	07011673	EUDAMED	Class IIa	Active
Stop Piolhos Loção	07011564	EUDAMED	Class I	Active
Elimax Ultra Power Spray	07011772	EUDAMED	Class I	Active
Nalox Easy	07011761	EUDAMED	Class IIa	Active
Stop Piolhos Loção – Anti Luis Lotion	07031061	EUDAMED	Class I	Active
Owix Hair S.o.s Szampon	07031124	EUDAMED	Class I	Active
Elimax Easy Power Lotion Spray	07011763	EUDAMED	Class I	Active
Box Licevex Täishampoo 100ml	07011748	EUDAMED	Class I	Active
Box Apaisyl® Anti-Poux Xpert Cire D’abeille 100ml	07011554	EUDAMED	Class I	Active
Label Parasidose Shampoing 2en1 100ml Fr	07030795	EUDAMED	Class I	Active
Label Apaisyl Anti-Poux Shampoing 3en1 200ml	07031074	EUDAMED	Class I	Active
Linicin Pluss Shampoo 100ml No	07010867	EUDAMED	Class I	Active
Metal Comb Blue No Logo With Udi	07080042	EUDAMED	Class I	Active
Prioderm Puur En Krachtig 100ml	07011274	EUDAMED	Class I	Active
Excilor Freeze	07011746	EUDAMED	Class IIa	Active
Box Elimax Shampoo 100ml Cz-Sk	07011620	EUDAMED	Class I	Active
Mosquito Med Läuse Shampoo 200ml	07010782	EUDAMED	Class I	Active
Pixie Skin Tag	K240226	FDA 510(k)	N/A	Active
Apaisyl® Anti-Poux Xpert Plus 100ml	07011549	EUDAMED	Class I	Active
Endwarts Freeze	07011674	EUDAMED	Class IIa	Active
Box Pouxit Flash Vegetal Lozione 100ml	07011508	EUDAMED	Class I	Active
Xtluis Natural Lotion Kam	07030926	EUDAMED	Class I	Active
Label Linicin Pluss Shampoo 100ml No	07030528	EUDAMED	Class I	Active
Becur Vårtfri Freeze	07011677	EUDAMED	Class IIa	Active
Excilor Easy It	07011526	EUDAMED	Class IIa	Active
Metal Comb Red No Logo With Udi	07080044	EUDAMED	Class I	Active
Aftir Duo Lotion 100ml	07030531	EUDAMED	Class I	Active
Box Elimax Pure Power Anti Laus Lösung 200ml	07011395	EUDAMED	Class I	Active
Box Elimax Shampoo 100ml Hu	07011657	EUDAMED	Class I	Active
Hedrin Once Natural Lotion	07011521	EUDAMED	Class I	Active
Apaisyl® Anti-Poux Xpert Plus 200ml	07030944	EUDAMED	Class I	Active
Box Apaisyl® Anti-Poux Xpert Cire D’abeille 200ml	07011555	EUDAMED	Class I	Active
Box Licevex Täishampoo 250ml	07011747	EUDAMED	Class I	Active
Box Xtluis Natural Lot Kam 100ml Hph Nl	07011522	EUDAMED	Class I	Active
Linicin Plus Solution 100ml Dk	07010769	EUDAMED	Class I	Active
Excilor Easy Cz-Sk	07011593	EUDAMED	Class IIa	Active
Box Bevitamed Täishampoo 100ml Fi	07011085	EUDAMED	Class I	Active
Endwarts Freeze	07011668	EUDAMED	Class IIa	Active
Elimax Natural Lotion 200ml	07011370	EUDAMED	Class I	Active
Box Elimax Pure Power 200ml Nl-Fr	07011395	EUDAMED	Class I	Active
Endwarts Extra Gegen Stielwarzen	07011684	EUDAMED	Class IIa	Active
Syylend Freeze	07011670	EUDAMED	Class IIa	Active
Bevitamed Täishampoo 250ml Fi	07011069	EUDAMED	Class I	Active
Excilor Easy Fi	07011628	EUDAMED	Class IIa	Active
Expert 1.2.3 CRYOSTYLO FROID EXTREME	07011534	EUDAMED	Class IIa	Active

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