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Organization name
UDI-DI code
Reference / catalog number

Stomachon — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 6, 2026

Stomachon

B-075044NT

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-075044NT
Reference / catalog number: 075044

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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
Warnings: • Do not take Irritable Bowel Syndrome capsules if you are hypersensitive or allergic to any of the ingredients; • Do not chew or bite the capsules. The capsules must not be allowed to dissolve in the mouth; • Keep out of reach of children; • Not suitable for children under the age of 12; • Irritable Bowel Syndrome capsules should not be taken at the same time with another drug. Use during pregnancy and/or breastfeeding: Despite the fact that the natural mineral clay and simethicone are not absorbed, No data is available about using Irritable Bowel Syndrom capsules during pregnancy or the breastfeeding period. If you are pregnant or breastfeeding, please consult your doctor or pharmacist before using this product. Possible side effects: Gastrointestinal symptoms are the main side effects of taking natural mineral clay; abdominal pain, bloating, diarrhoea and flatulence.

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Market distribution

Primary placement in Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement	Jun 4, 2019	Still on market

Device identification

Trade name: Stomachon
UDI-DI code: D-075044NT
Basic UDI-DI: B-075044NT
Reference / catalog number: 075044
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 relieve of painful symptoms and pressure of excess gas in digestive tract
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

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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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