Medical Devices

Laboratoire L`ideal Parisien Sp. z o.o. has been developing its competences in the production of Medical Devices for years. The implemented Quality Management System for medical devices in accordance with the MDR and the requirements of the ISO 13485 standard allows us to offer services in the field of design, production and packaging of medical devices of class I, class II and class III.

The compliance of the system was assessed during the examination by the certification body TUV Nord (CE 2274). 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 on the compliance of labeling and documentation accompanying the medical device.

We also offer support in the registration and notification of medical devices in all European Union countries. We have the ability to produce products in the form of liquid, cream, gel, emulsion and ointment.

Our R&D department develops new formulations in accordance with the MDR directive at the client's request.

Our products currently available for distribution in the private label variant are:

1) Class IIB according to MDR

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

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

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

2) Class I - in the transitional period (IIA according to MDR)

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

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

- canker sore gel with PVP - tube 20ml

- Eczema cream (emollient) – 100g tube and 500g jar

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

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

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

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

- Barrier diaper cream with lanolin equivalent – 50g and 100g tube

- Lice shampoo with dimethicone in a 100ml bottle

3) Class IIA (II B according to MDR)

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

In development:

- suppositories with hyaluronic acid

- suppositories with sucralfate for hemorrhoids

- gel with sucralfate for hemorrhoids

Please contact us for more details.

We believe that together we can build mutually beneficial relationships, also in the growing market of medical devices.

Please send inquiries regarding cooperation to [email protected] or [email protected]