Saatja: "Justine MOUISEL" <
[email protected]>
Teema: Information Request - Urogenital Mycoplasma Diagnosis
Kuupäev: 2023-11-29 09:39
To whom it may concern,
We are a leading Manufacturer of in vitro Medical Devices specialized in
urogenital mycoplasma diagnosis. In the context of the new European in
vitro Diagnostic Regulation 2017/746, we would like to have more
information regarding in vitro diagnostics in your country related to
urogenital mycoplasma and other communicable / infectious / opportunistic
infections and or diseases related to the urogenital sphere.
We would like to identify which IVD tests and analysis are currently
funded by your Health Ministry / Health Authority with regards to
urogenital diagnosis.
This information would be of great help to us to validate the continued CE
marking of this type of Mycoplasma test which are of important interest
for pregnant women, infertile couples and neonates etc.
Would you please have at your disposal the reimbursement rate of a
serological test (or any other diagnostic test) for the detection of
Mycoplasma hominis and Ureaplasma urealyticum/parvum ?
If you are unable to provide us with an answer, we would be very grateful
if you could please send us the name / contact of the Government
department or National body that is responsible for this area of health
policy in your country?
Thank you very much in advance for your help,
Kind regards,
Justine Mouisel
Ingénieur Affaires Réglementaires / Regulatory Affairs Engineer
[email protected] • www.elitechgroup.com
Tel: +33 4 83 69 21 08 / +33 4 83 69 21 09
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