Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

3757CE — Class I MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on Apr 29, 2026

3757CE

B-3757CETF

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-3757CETF
Reference / catalog number: 3757CE

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Related devices

RedCare Anti Fusspilz-gelB-17983001CUOn the market ABC Bacterial Vaginosis 5x7 mlB-954854SWOn the market Acetocaustin 2 mlB-073415NSOn the market ActiveMed D-Mannose 28 sB-073156NROn the market Activemed Flacher BauchB-073224NHOn the market

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Jul 9, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-3757CETF
Basic UDI-DI: B-3757CETF
Reference / catalog number: 3757CE
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-3757CETF

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

Become a partner of MD Atlas

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.