Laboratoire Lʻideal Parisien Sp. z o.o. has been developing its competences in the field of production of medical devices for years. The implemented Quality Management System for medical devices in accordance with the requirements of ISO 13485 allows us to offer services in the field of designing, production and packing of medical devices of class I, class II and class III.
The compliance of the system was assessed during the test by the certification body TUV Rheinland (CE 0197). We also have significant potential in the preparation and development of Technical Documentation for medical devices in accordance with the requirements of Directive 93/42 / EEC for our clients. We also consult the compliance of labeling and documentation accompanying a medical device.
We also offer support in the registration and notification of medical devices in all European Union countries. We can manufacture products in the form of liquid, cream, gel, emulsions and ointments.
Our R&D department develops new formulations compliant with the MDD directive at the customer's request.
Our products currently available as private label are:
1) Water-based lubricant - medical device, class IIa.
2) Silicone lubricant - medical device class IIa.
3) Intimate gel in the cannula - medical device class IIa.
4) Vaginal globules - medical device class IIa.
More products are being registered.
Please contact us for more details.
We believe that together we can build mutually beneficial relationships, also on the growing market of medical devices.
Please send inquiries regarding cooperation to the following address email@example.com or Adrian.firstname.lastname@example.org
L'IDEAL PARISIEN Sp. z o.o.
Al. Zygmunta Krasińskiego 14/3a, 30-101 Kraków
tel/fax + 4812/ 283 88 60