FTP021

Organization name

Labomar S.p.A.

SRN

IT-MF-000007965

Manufacturer status

Active

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

• CW999

  The applicator (cannula) is disposable. Throw the cannula after use. Women of childbearing age and those wishing to become pregnant should consult their gynecologist before using the device. Natural substances that compose the device make it coloured therefore, during and after the application, pay particular attention not to stain your clothing; Do not use in case of allergy to any component; Do not use after the expiry date; Do not use the product if the package is not intact; In case of burning or persistent itching, consult your doctor The expiry date refers to the product properly stored in intact package; Do not swallow; Keep out of the reach of children; Wash your hands before and after use; Do not use in case of ascertained hypersensitivity to any component of the product; Topical use;

Primary placement in Czechia; available across 2 countries total.

Trade name

not provided

UDI-DI code

D-FTP021_2HT

Basic UDI-DI

B-FTP021_2HT

Reference / catalog number

FTP021

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Regresil is a medical device designed for the treatment of microlesions caused by HPV or dryness.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-FTP021_2HT

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

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

Certificate health across this manufacturer's portfolio.