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

ULGIX FLATULENCE — Class III MDR by Przedsiębiorstwo…

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

EUDAMED last updated this device on Mar 9, 2026

ULGIX FLATULENCE

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: 05904055002888
Reference / catalog number: _

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: 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.

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 Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: ULGIX FLATULENCE
UDI-DI code: 05904055002888
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: 25
Additional product description: Medical device is used to relieve symptoms associated with the accumulation of gases in the intestines and to remove gases and air before diagnostic tests in the abdominal cavity by means of radiography, ultrasonography and endoscopy.
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)05904055002888

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

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

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

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

Become a partner of MD Atlas

Related devices

ULGIX FLATULENCE5904055001KQ3On the market ULGIX FLATULENCE5904055001KQ3On the market ULGIX FLATULENCE MAX5904055001KQ3On the market ULGIX FLATULENCE MAX5904055001KQ3On the market -5904055001KQ3On the market

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