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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

- — Class III MDR by Przedsiębiorstwo…

MD Atlas
Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.

EUDAMED last updated this device on Mar 11, 2026

-

5904055001KQ3

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.
UDI-DI code: 05904055004233
Reference / catalog number: -

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View device family (Basic UDI)

Manufacturer information

Organization name: Przedsiębiorstwo Produkcji Farmaceutycznej Hasco - Lek S.A.
SRN: PL-MF-000009264
Manufacturer status: Active

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW999
Do not exceed the recommended dose. Do not use the product after the expiry date.
CW999
Medical device should not be used in case of hypersensitivity to simethicone or any other ingredient of the product.
CW999
If a dose is missed, a double dose should not be administered to make up for the forgotten dose.
CW275
Stosowanie wyrobu w okresie ciąży i karmienia piersią wymaga konsultacji lekarskiej.
CW999
If previous symptoms persist or worsen and new gastrointestinal complaints occur, it is recommended to consult a doctor to determine the cause and begin treatment.
CW999
No clinically significant interactions of simethicone with drugs have been found; however, due to the likelihood of interactions, it is not recommended to take the medical device simultaneously with drugs.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904055004233
Basic UDI-DI: 5904055001KQ3
Reference / catalog number: -
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 10
Additional product description: Medical device is used to remove gases and air before performing diagnostic tests in the abdominal cavity by means of radiography, ultrasonography and endoscopy and to relieve symptoms associated with excessive accumulation of gases in the intestines.
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

Encoded

(01)05904055004233

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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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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Certificates

Certificate health across this manufacturer's portfolio.

1434-MDR-004/2026Issued
Technical documentationNotified body: 1434Expiry: Feb 11, 2031
1434-MDR-003/2026Issued
Quality management systemNotified body: 1434Expiry: Feb 11, 2031
1434-MDR-001/2024Issued
Quality management systemNotified body: 1434Expiry: Feb 28, 2029