Quality, testing & safety
Our commitment to quality.
From carefully selected raw material to final quality controls, discover the commitment to quality and safety behind KELOSCAR.
Sourcing & raw material quality
- Medical-grade silicone sourced from carefully selected suppliers
- Strict quality and purity specifications for raw materials
- Full traceability throughout the manufacturing process
Manufacturing excellence
- Developed and manufactured in Europe
- Controlled manufacturing processes
- Quality management processes aligned with ISO 13485
Independent testing & safety
- Dermatologically tested by Dermatest®, with an “Excellent” skin tolerability rating
- Raw materials subject to defined safety and quality requirements
- Formulated with carefully selected ingredients
Regulatory compliance
- CE-marked Class I medical device under Regulation (EU) 2017/745 (MDR)
- Formulated without intentionally added D4, D5 or D6 silicones, with residual levels controlled according to product specifications
- CE marked
- Class I medical device · EU MDR 2017/745
- Made in Europe
- Dermatest
- ISO 13485 aligned
- No added D4 · D5 · D6
Continuous improvement & feedback
Your feedback matters.
We value feedback from KELOSCAR users and healthcare professionals. Your experiences and suggestions help us continuously improve our products, enhance the user experience and strengthen the support we provide.
Reporting a serious incident: if you experience a serious incident involving a KELOSCAR product, please report it to the legal manufacturer, Innov-Cell Therapeutics, at info@innovcell.com, and to the competent authority in your country.
