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Organization name
UDI-DI code
Reference / catalog number

FDG Fungal nail treatment — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 1, 2026

FDG Fungal nail treatment

B-DS0066443H9

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-DS0066443H9
Reference / catalog number: DS066443

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View device family (Basic UDI)

Manufacturer information

Organization name: PK Benelux BV
SRN: NL-MF-000006672
Manufacturer status: Active

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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.

Critical warnings

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

CW999
Warnings:  For external use only.  Fungal nail might cause erythema, irritation, edema, pain, nail discoloration and onycholysis.  Check the list of ingredients to know if you are allergic to any of the ingredients contained in the gel.  Avoid contact with eyes or mucous membranes.  Do not apply to open wounds or damaged skin.  Do not bandage tightly.  Do not apply heat to the area of application.  Pregnant or breastfeeding patients should seek advice of health professional before using Fungal nail.  If you experience allergic reactions, stop using the product.  Keep out of reach of young children.  In case of no effect, consult a physician. Use during pregnancy and/or breastfeeding: No information is available regarding the use of (Brand®) Fungal Nail during pregnancy or the breastfeeding phase. If you are pregnant or breastfeeding, consult your doctor or pharmacist before using. Side effects:  Possible side effects includes: erythema, irritation, edema, pain, nail discoloration and onycholysis.  allergic reactions.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Dec 10, 2020	Still on market

Device identification

Trade name: FDG Fungal nail treatment
UDI-DI code: D-DS0066443H9
Basic UDI-DI: B-DS0066443H9
Reference / catalog number: DS066443
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: To treat nail fungal infections (onychomycosis) on hands and feet in adults.
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-DS0066443H9

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.

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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