Medical Devices

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) Class IIa (IIB according to MDR)

- water lubricant (tube/airless/bottle/sachets)

- silicone lubricant (tube/airless/bottle/sachets)

- vaginal pessaries with hyaluronic acid and lactic acid (2, 7, 10, 14 pcs in a box)

- vaginal gel with hyaluronic acid and lactic acid (2, 5, 7, 10, 14 5ml tubes in a box)

2) Class I (IIA according to MDR)

- scar gel based on silicones with Biogenic Gensil 210L - tube 15 and 20ml

- teething gel with saffron and PVP - tube with massager 15ml

- mouth ulcer gel with PVP - 20ml tube

- eczema cream (emollient) - 100g tube and 500g jar

- antiviral nasal spray gel (exclusive to some countries) glass bottle 20ml

- antiviral throat spray gel (exclusive to some countries) 20ml glass bottle

- throat rinse for HPV with carrageenan and PVP - 200ml bottle

- HPV intimate spray with carrageenan and tannin - 200ml bottle

- diaper barrier cream with lanolin equivalent - 50g and 100g tube

- head lice shampoo with dimethicone in a 100ml bottle

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 irena.baranek@lideal.pl or Adrian.baranek@lideal.pl