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

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Organization name
UDI-DI code
Reference / catalog number

Gel Aphte Repair — Class I MDD by UNIFARCO SpA

MD Atlas
UNIFARCO SpA

EUDAMED last updated this device on Jan 8, 2026

Gel Aphte Repair

B-FPGAFT10FEY

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: UNIFARCO SpA
UDI-DI code: D-FPGAFT10FEY
Reference / catalog number: 8029408130647

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View device family (Basic UDI)

Manufacturer information

Organization name: UNIFARCO SpA
SRN: IT-MF-000013304
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW275
L’état actuel des connaissances ne permet pas d’affirmer l’existence d’un quelconque risque pour la santé ni de contre-indications, en cas de grossesse ou d’allaitement
CW135
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: Gel Aphte Repair
UDI-DI code: D-FPGAFT10FEY
Basic UDI-DI: B-FPGAFT10FEY
Reference / catalog number: 8029408130647
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: —
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

EMDN nomenclature code(s)

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

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.