Naturelle Consumer Products

Naturelle Consumer Products specializes in disposable contamination control, infection control, and hygiene products. Their portfolio includes sterile and non-sterile wipes (such as Hypaclean, Action, and LIDESSENCE), personal protective clothing, cleanroom consumables, and medical-grade solutions like Astroplast and Werosalin. These products are designed for medical, pharmaceutical, industrial, and retail markets, addressing needs like wound care (e.g., Boots Wound) and general hygiene (e.g., Body Doctor).

Naturelle Consumer Products is based in XI, which is a key factor in its regulatory compliance as it must adhere to the EU’s medical device regulations. Since their products fall under EU classifications (Class I and Class IIa), they are required to list all relevant devices in the EU’s official registry, eudamed, to ensure transparency and traceability. This alignment with EU standards reflects their commitment to meeting regulatory requirements for disposable medical and hygiene consumables.

Naturelle Consumer Products’ devices are listed in the eudamed registry, which is the EU’s central database for medical devices. This registry ensures that all Class I and Class IIa devices—such as their wipes, protective clothing, and medical-grade solutions—are publicly documented, supporting traceability and compliance with EU medical device regulations.

Naturelle Consumer Products’ devices are classified under the EU’s medical device regulations as Class I (generally low-risk items like non-sterile wipes or basic personal protective clothing) and Class IIa (moderate-risk items such as sterile wipes or certain wound care products). This classification determines the regulatory scrutiny and requirements they must meet, including mandatory listing in eudamed for transparency and compliance.