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Organization name
UDI-DI code
Reference / catalog number

Mivagyn Bor — Class IIa MDD by GRUPPO FARMAIMPRESA SRL

MD Atlas
GRUPPO FARMAIMPRESA SRL

EUDAMED last updated this device on Apr 20, 2026

Mivagyn Bor

B-FT.CE.111.FA.155K

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.FA.155K
Reference / catalog number: FT.CE.111

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View device family (Basic UDI)

Manufacturer information

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

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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
Keep out of reach of children. Do not swallow. Do not use if package is damaged. Do not use the product after the expiry date. The expiry date refers to unopened and properly stored product. Do not use the product in case of vaginal lesions and wounds. Do not use the product during menstruation. Do not exceed the suggested dosage without medical advice. The use, especially if prolonged, can lead to sensitiveness events. If this is the case, stop the treatment and consult the doctor in order to start a proper therapy. It is important to inform the doctor or the pharmacist of any undesired effects non reported in the insert leaflet. Do not use the product for more than 30 consecutive days.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Mar 18, 2020	Still on market

Device identification

Trade name: Mivagyn Bor
UDI-DI code: D-FT.CE.111.FA.155K
Basic UDI-DI: B-FT.CE.111.FA.155K
Reference / catalog number: FT.CE.111
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: MIVAGYN BOR is a medical device that helps recovering the natural vaginal defenses. Containing Boric Acid, Lactic acid, Polycarbophyl it helps delete the symptoms due to unbalanced vaginal pH and of endogenous bacterial flora.
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.FA.155K

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

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