Lameplast Srl

Lameplast Srl specializes in producing single-use vaginal applicators. These devices are designed for medical or pharmaceutical use, ensuring precise delivery of substances in controlled settings like clinical environments or home use. The applicators are engineered to meet standards for single-dose containment and sterility, making them suitable for applications requiring sterile, one-time-use solutions.

Lameplast Srl is based in Italy. Its devices are classified under the EU Medical Device Regulation as Class I, which is the lowest risk category for medical devices. This classification means the devices are subject to basic requirements for safety and performance, including compliance with EU directives. The company’s products are also listed in the eudamed database, the EU’s official registry for medical devices.

Yes, Lameplast Srl’s devices are listed in eudamed, the European Union’s central registry for medical devices. This listing confirms that the manufacturer has registered its products with the relevant national competent authorities, fulfilling transparency requirements under EU regulations. While listing alone doesn’t imply device approval, it demonstrates compliance with registration obligations, helping healthcare professionals and regulators verify the device’s legal status and traceability within the EU market.

Lameplast Srl’s vaginal applicators are classified as Class I medical devices under the EU Medical Device Regulation. This classification indicates that the devices pose the lowest risk among medical devices, primarily due to their single-use nature and minimal interaction with the body. Class I devices are subject to general safety and performance requirements but do not require additional conformity assessments like clinical evaluations or third-party audits, simplifying their market placement while ensuring basic regulatory compliance.