Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Boragina ovules — Class IIa MDD by GRUPPO FARMAIMPRESA SRL

MD Atlas
GRUPPO FARMAIMPRESA SRL

EUDAMED last updated this device on Apr 21, 2026

Boragina ovules

B-FT.CE.111.FB.763

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: GRUPPO FARMAIMPRESA SRL
UDI-DI code: D-FT.CE.111.FB.763
Reference / catalog number: FT.CE.111.FB.7

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

Organization name: GRUPPO FARMAIMPRESA SRL
SRN: IT-MF-000012625
Manufacturer status: Active

Related devices

FT.MDR.16.8.10805574884FTCE16-267UOn the market ACID-EAZE PLUSB-FT.CE.107.FA.5.12RROn the market FT\MDR\26.14.100805574884FTCE16-267UOn the market FT\MDR\26.14805574884FTCE16-267UOn the market ALGIBABY SODB-FT.CE.107.FH.1.12TQOn the market

Certificates

Certificate health across this manufacturer's portfolio.

021-00-05-MDRSupplemented
Technical documentationNotified body: 0426Expiry: Jun 21, 2028
009-00-19-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Jan 9, 2028
020-00-04-MDRWithdrawn
Quality management systemNotified body: 0426Expiry: Jun 21, 2028
010-00-06-MDRWithdrawn
Quality management systemNotified body: 0426Expiry: Jan 9, 2028

Critical warnings

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

CW999
The device does not require any special precautions for use. However, we recommend: Keep out of reach of children. Do not ingest. Do not use the product if the packaging is damaged. Do not use the product after the expiration date. The expiration date refers to the intact and properly stored product. Do not use the product if you have vaginal lesions or wounds. Do not use during menstruation. Do not exceed the recommended dose without consulting your doctor. Use, especially if prolonged, may cause sensitization. If this occurs, discontinue treatment and consult your doctor to initiate appropriate treatment. It is important to report to your doctor or pharmacist any side effects not described in this leaflet. Do not use the product for more than 30 consecutive days.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Nov 2, 2020	Still on market

Device identification

Trade name: Boragina ovules
UDI-DI code: D-FT.CE.111.FB.763
Basic UDI-DI: B-FT.CE.111.FB.763
Reference / catalog number: FT.CE.111.FB.7
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: dispositivo medico che aiuta a mantenere intatte le difese naturali della vagina ed agevola il ripristino della flora vaginale; a base di acido borico ed acido lattico aiuta ad eliminare i sintomi conseguenti ad uno squilibrio del pH vaginale.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-FT.CE.111.FB.763

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

EMDN nomenclature code(s)

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

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

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Become a partner of MD Atlas