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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

Hydrogel — Class I MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on Apr 30, 2026

Hydrogel

B-200000536DM

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-200000536DM
Reference / catalog number: 200000536

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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
Check the list of ingredients to know if you are allergic to any of the ingredients contained in the spray. If you experience allergic reactions, stop using the product. The formula contains potentially proconvulsant essential eucalyptus oil and should be avoided by individuals with epilepsy. Keep out of reach of young children. Side effects: Some people may experience nasal irritation and burning, and in very rare cases bleeding of the nose.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Jul 10, 2025	Still on market

Device identification

Trade name: Hydrogel
UDI-DI code: D-200000536DM
Basic UDI-DI: B-200000536DM
Reference / catalog number: 200000536
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 treat allergic and nonallergic rhinitis in adults, pregnant or breastfeeding women and children older than 3 years old.
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-200000536DM

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.

Q030103NASAL IRRIGATION SOLUTIONS

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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