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Organization name
UDI-DI code
Reference / catalog number

Mycoflash spray 25 ml — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 1, 2026

Mycoflash spray 25 ml

B-750210PN

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-750210PN
Reference / catalog number: 750210

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View device family (Basic UDI)

Manufacturer information

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

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: • Keep out of reach of small children; • If you are allergic to one of the ingredients or experience an allergic reaction, stop using Athlete’s foot spray; • Only for external use; •Avoid contact with eyes or mucous membranes; • Consult your doctor when you do not see an improvement within two weeks; • The product contains camphor, potentially causing seizures and should be avoided by people with epilepsy • Consult your doctor when you do not see an improvement within two weeks Side effect(s): There are no reported serious side effects. Side effects could be skin irritation such as itching, swelling, rashes and redness. Use during pregnancy and/or breastfeeding: No data is available about using Athlete’s Foot Spray during pregnancy or the breastfeeding period. If you are pregnant or breastfeeding, please consult your doctor or pharmacist before using this product.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 29, 2025	Still on market

Device identification

Trade name: Mycoflash spray 25 ml
UDI-DI code: D-750210PN
Basic UDI-DI: B-750210PN
Reference / catalog number: 750210
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 support the treatment of fungal infections of the foot (tinea pedis).
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-750210PN

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.

M04041503DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS

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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