Products

Besides hormonal contraception, copper-IUDs are the most effective and safe method of contraception.

Patients looking for safe and long-term precautions without hormones will decide for a copper-IUD. Up to now copper-IUDs are still the most common way of contraception worldwide.

The main concern of Mona Lisa N.V. is to sell high quality products at lower prices than equivalent original products. The product range covers all main versions of copper-IUDs which have been proven and well known for years in various markets. Mona Lisa products are defined as being similar or identical to the original products like "Multiload Cu 375/375 SL" by Organon, "Nova T 380" by Schering, "Flexi T 300" by Prosan or as replacements of well known but no more available products like the "Gyne-T" from Janssen Cilag.

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. The higher the copper surface the longer the in-situ-time within the patient´s body (from 5-10 years). The copper has a purity level of 99,99 %. The return thread at the bottom end of the body is composed of tear-proof polyamide nylon 6.

Cu375 / 375 SL

This model is completely identical with the long-term tried and trusted bestseller "Multiload Cu 375/375 SL".
Insertion requires a one-hand technique only without preloading.

This Mona Lisa model is available in two versions:

Cu375
With a copper surface of 375 mm² this version guarantees 5 years of safe contraception.

Unique features:

  • One-hand technique for insertion
  • low expulsion rate due to the flexible IUD-body


Cu375 SL
This version is identical to the Mona Lisa Cu 375,only differing in the dimension.

Unique features:

  • the stem length (29,4 mm) is 5 mm shorter compared to the Mona Lisa Cu375
  • ideally suited for patients with shorter uterus length

CuT 380A

This model is not only a rebuilt but even an improvement of the former, no more available "Gyne-T".
The classic T-shaped IUD is the most common used IUD-model in the world, recommended even by the WHO. It convinces through secure fit in the uterus, lowest Pearl-Index and a minimal expulsion rate.
Before insertion, the IUD has to be preloaded, which means that the horizontal arms have to be bended into the tube. For easy loading a loading capsule is enclosed.

Unique features:

  • The Mona Lisa CuT 380A has a copper surface of 380 mm² and guarantees safe contraception up to 10 years. (recommendation of the WHO)
  • The copper sleeves are completely embedded in the horizontal arms. This results in a very smooth and plane surface as well as in a small diameter of the tube (4.4 mm)
  • Small dimension of the loaded IUD with easy insertion
  • Easy handling through loading capsule

CuT 380A QL

This model is an improved rebuilt of the former, no more available “GyneT” with a new technology for quick and safe loading of the IUD.
The classic T-shaped IUD is the most common used IUD-model in the world, recommended even by the WHO. With a copper surface of 380 mm² it shows the lowest pearl index among all copper IUDs.

Mona Lisa CuT 380A QL convinces through secure fit in the uterus and in consequence low expulsion rate because of optimal memory test results.

Before insertion, the IUD has to be preloaded by using the plunger. Due to the development of the insertion body, loading of the IUD is possible in seconds.

Unique features:

  • The Mona Lisa CuT 380A has a copper surface of 380 mm² and guarantees safe contraception up to 10 years (recommendation of the WHO)
  • The copper sleeves are completely embedded in the horizontal arms. This results in a very smooth and plane surface
  • The longer insertion tube of the Mona Lisa CuT380A QL improves positioning of the IUD with patients with a longer uterine cavity
  • Effortless and quick loading of the IUD because of the new insertion body

NT Cu380 / 380 Mini

This Mona Lisa model has the same design as the "Nova T 380".
Also this model requires preloading before insertion. In contrast to the CuT 380A version, the horizontal arms are to be pulled into the tube.

This Mona Lisa model is available in two versions:

NT Cu380
With a copper surface of 380 mm², this IUD model guarantees safety up to 5 years.

Unique features:

  • Simple handling
  • Easy and painless insertion and removal
  • Low PID (Pelvic inflammatory disease) rate


NT Cu380 Mini
The NT Cu380 Mini has identical features like the NT Cu380 and differs only in the dimension from the standard model.

Unique features:

  • less stem length as well as less width of the side arms compared to the NT Cu380
  • ideally suited for women with a uterus length < 7 cm

ST Cu300

The Mona Lisa ST Cu300 is a rebuilt of the Flexi T 300 which has been on the market since a long time. At the lower end of the IUD a secure double nylon thread system is fixed to the IUD body. The CU-Safe T 300 has a copper surface of 300 mm² and guarantees safe contraception up to 5 years.

The ST Cu300 has not to be preloaded; insertion takes place with a one-hand technique.

Unique features:

  • Optimally suited for Nullipara, but also for Uni- and Multipara with a small uterus size
  • Easy and pain free insertion and removal due to the small size of the IUD
  • Low expulsion rate due to the shape optimally fitted to the uterus

Aspiration Needles for the IVF

Mona Lisa N.V. is also manufacturer of "Aspiration Needles" for the field of IVF. Mona Lisa acts thereby as contract manufacturer for the company "Gynotec" which distributes the Aspiration needles worldwide, in Europe under their own CE-mark and in the US under their FDA approval.

The needle is made of chirurgical steel especially designed for IVF. Tubing and handle are made of High Density Polyethylene, recommended for gamma radiation. The cork (bong) is made of medical grade silicon, especially designed for gamma radiation.

The composition of these materials guarantees no interference with the sterilization method used. This is very important to avoid the development of radicals e.g. with radiation and gives maximum security for non embryo toxicity.

For the US the product is sold with a mouse embryo test certificate. For Europe this certificate can be produced on request.

To make the oocyte retrieval as patient friendly as possible and to enhance the precision of puncturing some extra afford was done:

  1. The needle point is extra sharp not only by design but also by extra polishing.
  2. The handle has a two finger grip enhancing the control of the punction.
  3. The visibility on the echo screen is very good because of the double laser mark immediately at the point of the needle.
  4. Together with the bevel indicator on the handle this provides maximum control to the physician.

Products:

Mona Lisa Aspiration Needles are available in the following specifications:

Consulting

Our long lasting expertise and knowledge in the production and distribution of medical devices (Class III) in the field of gynaecology, opens us the possibility to give you consultancy in the following topics:

  • Implementation of a quality management system under ISO 9001:2008, ISO 13485:2003, EN ISO 13485:2012
  • Assistance in the technical documentation for medical devices (Class II and III)
  • Development and production of moulds for plastic bodies used in the medical device area.
  • Support in implementing a product line or single products as well as the complete production of these including all relevant quality steps during production and final release of the goods.
  • Production of medical device products in class 100.000 (ISO 8) areas.

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