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 requirements of the ISO 13485 standard allows us to offer services in the field of preparation, production and packaging of class I, class II and class III medical devices.

The compliance of the system was assessed during testing by the TUV Nord certification body (CE 2274). We also have significant potential in preparing and developing 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 a medical device.

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

Our R&D department develops new formulations compliant with the MDR directive at the customer's request.

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

1) Class IIa (IIB according to MDR)

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

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

- vaginal globules 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 carton)

2) Class I (IIA according to MDR)

- silicone-based scar gel from Biogenic Gensil 210L - 15 and 20 ml tube

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

- PVP gel for canker sores - 20ml tube

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

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

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

- HPV gargle with carrageenan and PVP – 200ml bottle

- spray for intimate areas against HPV with carrageenan and tannin - 200ml bottle

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

- lice shampoo with dimethicone in a 100 ml bottle

Under development:

- Glycerine suppositories

- 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 on the growing medical device market.

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