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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

Audisol — Class I MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on Apr 29, 2026

Audisol

B-073033DKSHCJ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-073033DKSHCJ
Reference / catalog number: 073033DKSH

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View device family (Basic UDI)

Manufacturer information

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

Critical warnings

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

CW999
The ear spray must not be used in the case of inflammation of the ear or earache, foreign objects in the ear, perforation of the eardrum or by anyone with eardrum tubes. Stop using the ear spray if ringing in the ears (tinnitus) or dizziness occurs or if pain is repeatedly experienced immediately after the ear spray is applied. Consult your doctor in case of doubt. Ear spray must not be used by anyone who is hypersensitive to (has an allergy) one or more of the ingredients. Skin reddening, itchiness, persistent weeping or earache immediately after spraying may be an indication of hypersensitivity. The spray contains soap and may cause irritation if used in the mouth or eyes. If the spray should be accidently sprayed in the mouth or eye, immediately rinse the affected area using plenty of water. The use during pregnancy or lactation is only recommended after consultation with your doctor.

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Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Jan 11, 2019	Still on market

Device identification

Trade name: Audisol
UDI-DI code: D-073033DKSHCJ
Basic UDI-DI: B-073033DKSHCJ
Reference / catalog number: 073033DKSH
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: To remove cerumen congestion in adults and children older than 3 years
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-073033DKSHCJ

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.

Q03040299EAR IRRIGATION DEVICES - 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.