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Organization name
UDI-DI code
Reference / catalog number

SV Verruche CE 4 ml — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 4, 2026

SV Verruche CE 4 ml

B-018478NK

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-018478NK
Reference / catalog number: 018478

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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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Critical warnings

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

CW999
Not for pregnant women or while breastfeeding Not for children aged 3 years and younger Do not use Wart Away: • If you are oversensitive to one or more of the ingredients; • In the face (the fluid should never make contact with the eyes or the mucous membrane in the nose or mouth); • For genital warts or in the genital area; • On birthmarks, water warts, open wounds, moles, naevus, senile (brown) warts, plantar warts, darkly coloured, hairy or strange looking warts; • On red, irritated or infected warts; • Immediately after a surgical removal of warts, freezing of warts (cryotherapy) or a laser treatment. This particularly applies when the skin is red or painful after the treatment. In this case you will have to wait for at least 4 weeks, until the redness or inflammation of the skin has fully disappeared. Only then you can start using Wart Away; • During pregnancy or while breastfeeding; • Do not use on warts which occur completely or partly underneath the nail. • Do not use on warts that occur completely or partially on the sole of the feet (plantar warts). Use in combination with drugs: As far as we know, there are no interactions with drugs. Possible side effects: Wart Away may cause some side effects, although not everyone will experience these side effects. The side effects that could occur when using Wart Away are: irritated skin, burning sensation, skin redness or oversensitivity reactions. If any of these side effects becomes serious, or if you notice any side effects not listed in these instructions for use, please consult your doctor or pharmacist.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Feb 28, 2018	Still on market

Device identification

Trade name: SV Verruche CE 4 ml
UDI-DI code: D-018478NK
Basic UDI-DI: B-018478NK
Reference / catalog number: 018478
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 nongenital warts (Verruca vulgaris) due to the mechanical destruction of wart tissue
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-018478NK

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.

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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.