quality inside - mona lisa® iup - eurimpharm€¦ · mona lisa is certified in accordance with the...

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Page 1: Quality inside - Mona Lisa® IUP - EurimPharm€¦ · Mona Lisa is certified in accordance with the thorough Quality Management System (actually valid ISO 13485), that is subject

Quality inside

Page 2: Quality inside - Mona Lisa® IUP - EurimPharm€¦ · Mona Lisa is certified in accordance with the thorough Quality Management System (actually valid ISO 13485), that is subject

IUDs according to international standardsIUDs from Mona Lisa are generics of the classic copper IUDs that have been on the market for many years.

Today Mona Lisa offers all current IUD models. The selection of the most suitable IUD depends in the main on individual patient wishes and requirements.

The body of the IUD is made of Polyethylene with copper wire wound around the stem. The addition of Barium Sulphate enables radiological proofing.

The total copper surface area varies between 300 mm2 and 380 mm2 allowing a different in-situ-time of the IUDs (between 5 and 10 years).

The copper has a purity level of 99,99 %. Undesirable allergic reactions can therefore be excluded.

The return thread at the bottom end of the body is composed of tear-proof Nylon.

ST

Mona Lisa Intrauterine Devices -

Same design as „Flexi T 300“ Easy, painfree insertion and removalSecure double nylon thread system

Mona Lisa ST Cu300- Copper surface: 300 mm2 - Also suited for uni- and- In-situ-time: 5 years multipara with smaller uteri - Optimally suited for nullipara - Stem length: 29,2 mm

CuT Optimal, secure fit in the uterus: minimal expulsion rate.

Available in two versions:

Mona Lisa CuT 380A Mona Lisa CuT 380A QL- Copper surface: 380 mm2 - Identical characteristics to- In-situ-time: 10 years Mona Lisa CuT 380A- IUD with the lowest - Easy and quick loading of Pearl Index the IUD due to the new

technology

Page 3: Quality inside - Mona Lisa® IUP - EurimPharm€¦ · Mona Lisa is certified in accordance with the thorough Quality Management System (actually valid ISO 13485), that is subject

Mona Lisa is certified in accordance with the thorough Quality Management System (actually valid ISO 13485), that is subject to numerous controls through the national surveillance authorities.

All products carry the internationally valid -mark.

Complete physician´s instruction and patient information according to ISO 7439:2015.

Quick-load insertion system with the Mona Lisa CuT 380A QL.

Loading capsule with the Mona Lisa CuT 380A ensures easy insertion of the side arms into the insertion tube.

Tear-proof and yet soft, pliant nylon threads and safe, firm sitting copper cover guarantees minimal irritation in the vagina.

Secure, tear-proof sterile packaging (Tyvek).

Quality advantage through Mona Lisa IUDs

High quality at low prices

Form and composition same as the long-year tried and trustedbest seller „Multiload“.

Available in two versions:

Mona Lisa Cu375 Mona Lisa Cu375 SL- Copper surface: 375 mm2 - Identical characteristics to- In-situ-time: 5 years the Mona Lisa Cu375- One-handed insertion - Shorter stem length (29,4 mm).

technique Ideally suited for a shorter uterus length

Same design as „Nova T“ Easy, painfree insertion and removal

Available in two versions:

Mona Lisa NT Cu380- Copper surface: 380 mm2

- In-situ-time: 5 years - Low Pearl Index

Cu

NT

Mona Lisa NT Cu380 Mini- Identical characteristics to

the NT Cu380- Optimally suited for women

with a uterus length between 5 and 8 cm

Page 4: Quality inside - Mona Lisa® IUP - EurimPharm€¦ · Mona Lisa is certified in accordance with the thorough Quality Management System (actually valid ISO 13485), that is subject

Magnetic Resonance Therapie (MRT/MRI):MR-examinations in a strength of up to 3.0 Tesla in women who have a copper intrauterine device for contraception (IUD) in place, does not influence neither the results of the MR-examination nor the functional efficacy of the IUD.

More Information at www.monalisa.eu

Useful Information about Mona Lisa IUDs

Contact:

Sales office Germany: Mona Lisa N.V.P.O. Box 01D-83416 Saaldorf-Surheim

Mr. Thomas ValeriusMs. Elisabeth AdomaitisPhone: +49 8654 7707-146 Fax: +49 8654 7707-189

Mail: [email protected]

Production office Belgium:Mona Lisa N.V.Graaf de Theuxlaan 25, bus 2B-3550 Heusden-Zolder

Mr. Frank DaniëlsMr. Marc Peetermans Phone: +32 1145 59-90Fax: +32 1145 59-91

www.monalisa.eu

Consulting• Implementation of a QM-System under actually valid ISO 13485• Assistance in the technical documention for medical devices• Development and production of moulds for plastic bodies• Support in implementing a product line• Production of medical device products class II and III

Mona Lisa Intrauterine Device Width (mm) Length (mm) Maximum Insertion

Time in the Body Recommended Uterus

Length

Mona Lisa Cu375 19,5 35,2 5 years 6 – 9 cm

Mona Lisa Cu375 SL 19,5 29,4 5 years 5 – 8 cm

Mona Lisa CuT 380AMona Lisa CuT 380A QL 31,9 35,9 10 years 6 – 9 cm

Mona Lisa NT Cu380 31,8 31,9 5 years 6 – 9 cm

Mona Lisa NT Cu380 Mini 24,0 30,0 5 years 5 – 8 cm

Mona Lisa ST Cu300 22,9 29,2 5 years 5 – 8 cm

Dimensions / Insertion Time / Recommended Uterus Length of Mona Lisa IUDs:

MO

/901

0120