Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

N/A — Class III MDR by WALMARK, a.s.

MD Atlas
WALMARK, a.s.

EUDAMED last updated this device on Apr 14, 2026

N/A

8596024DEGASIN280MG2K

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: WALMARK, a.s.
UDI-DI code: 08596024030069
Reference / catalog number: N/A

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?

Manufacturer information

Organization name: WALMARK, a.s.
SRN: CZ-MF-000007035
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW999
Contraindications: • in case of known hypersensitivity to simethicone or to any of the ingredients • in case of known or suspected perforation or obstruction of digestive tract • in children
CW999
Concomitant administration of levothyroxine and simethicone may lead to decreased efficacy of levothyroxine and thus decrease function of thyroid gland.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW267
softgel made from fish gelatin
CW999
Do not dispose the product or its packaging into environment.
CW275
safety of simethicone use during pregnancy has not been evaluated
CW999
Please report any serious incident that has occurred in relation to the use of Degasin 280 mg to the manufacturer and the competent authority. If your symptoms are not improving or are worsening, it's advisable to consult your doctor or pharmacist.
CW999
Do not use this medical device if it was exposed to temperatures outside the specified storage conditions.

Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08596024030069
Basic UDI-DI: 8596024DEGASIN280MG2K
Reference / catalog number: N/A
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: 1
Additional product description: —
Additional information URL: https://www.degasin.eu/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G99GASTROINTESTINAL 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

N/A8596024DEGASIN280MG2KOn the market N/A8596024DEGASIN280MG2KOn the market N/A8596024DEGASIN280MG2KOn the market

Certificates

Certificate health across this manufacturer's portfolio.

2026-MDR/TD-011/ASupplemented
Technical documentationNotified body: 2265Expiry: Jan 30, 2031
2026-MDR/QS-011/ASupplemented
Quality management systemNotified body: 2265Expiry: Jan 30, 2031