Silicone menstrual cup Imasafe®

Product Overview
Imasafe® menstrual cup is a reusable intravaginal device designed to collect menstrual fluid during menstruation. The cup is a flexible, funnel-shaped device made of 100% medical-grade liquid silicone rubber, available in three capacities for clinical and consumer use.

Technical Specification

• Material: 100% medical-grade liquid silicone rubber.
• Manufactured in Clean Room ISO Class VII.
• Produced and tested by qualified rubber technologists and engineers.
• Developed in an advanced R&D laboratory.

Compliance & Certifications

• FDA 21 CFR 177.2600 compliance.
• ISO 10993-10 Skin Sensitization test.
• ISO 13485 certified manufacturing.
• ISO 10993-3 Genotoxicity test.
• RoHS compliant.
• BPA free.
• TSE/BSE free.
• Phthalate free.
• ISO 10993-4 Hemolysis test.
• ISO 10993-23 Vaginal Irritation test.
• ISO 10993-5 Cytotoxicity test.
• FDA registered facility.

Advantages

• Safer alternative to disposable pads and tampons when used according to instructions.
• Cost-effective and environmentally sustainable solution.
• Higher fluid capacity compared with many single-use products.
• Designed to minimize leakage, odor and skin irritation when used correctly.
• Can be worn up to 8 hours depending on flow and clinical guidance.

Our Strength

• Manufactured in an ISO Class VII clean room facility.
• Efficient logistics and reliable lead times for bulk orders.
• Private label and custom packaging options available.

Characteristics

• Size: 3 sizes — Small (15 ml), Medium (25 ml), Large (30 ml).
• Stem: Facilitates location and removal of the cup.
• Air Holes: Support suction to reduce leaks.
• Ridges: Provide grip for secure removal.
• Smoother Rim: Flexible rim to ease insertion and opening.
• Appearance / Colours: Translucent, Purple, Aqua Green, Pink, Red, Black.
• Shelf life: 5 years.

Technical Specifications

• Material: 100% medical-grade liquid silicone rubber.
• Manufacturing environment: Clean Room ISO Class VII.
• Biocompatibility tests: ISO 10993 series (skin sensitization, genotoxicity, hemolysis, vaginal irritation, cytotoxicity).
• Regulatory: FDA registered; compliant with FDA 21 CFR 177.2600 and RoHS.
• Free from BPA, phthalates, TSE/BSE.
• Available volumes: Small 15 ml, Medium 25 ml, Large 30 ml.
• Design features: stem for removal, air holes for suction, ridges for grip, smoother rim for insertion.
• Colours: Translucent / Purple / Aqua Green / Pink / Red / Black.
• Intended usage time: up to 8 hours per wear.
• Shelf life: 5 years.