TEN fertil ZEL

Trade name

TEN fertil ZEL

D-FT.CE.109.8CL

B-FT.CE.109.8CL

Reference / catalog number

FT.CE.109.8

EUDAMED

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

is a vaginal gel formulated to: •Create an optimal environment for spermatozoa • Contribute to maintaining a pH value suitable for natural conception • Obtain an osmolarity compatible with the seminal fluid

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Keep out of reach of children. Single-dose applicators: the content of each tube should be used in a single administration. Store the product properly sealed and protected from light and heat sources. Do not use the product after the expiry date reported on the packaging. The expiry date is valid for the product properly stored. Do not use the product if the package is damaged or opened. The device is not sterile. It's not a contraceptive. TENfertil gel has no spermicidal activity. Do not use in case of damaged mucous membranes, post-surgery or acute vaginal infection. Do not swallow. Avoid contact with eyes. Do not use in case of individual ascertained hypersensitivity to the components present into the product. Do not use the product in conjunction with quaternary ammonia compounds. The incorrect observance of the warnings, of the methods of use, as well as the re-use of the same single-dose applicator could compromise the efficacy of the product or cause the aggravation of existing problems or cause the onset of problems that were not previously present. For lactating women, the use of the gel should be limited to cases of real need and under the direct supervision of the doctor. Do not use the product for a period exceeding 30 consecutive days. It is important to inform your doctor or pharmacist of any side effects not described in this leaflet.