- Organization name
- UDI-DI code
- Reference / catalog number
PL-MF-0000071271434-MDD-227/20211434-MDD-226/2021Simethicon 80 mg is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by Curtis Health Caps S.A.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Sep 29, 2022
B-M012FAPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-M012FA
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
11 warnings recorded — scroll inside the panel to see all entries.
If you have any doubts regarding the use of this medical device, consult your doctor or pharmacist. The product can be used by pregnant women and during breastfeeding after consulting a doctor or pharmacist.
The device should not be used if you are hypersensitive to simethicone or any other component of the device.
Contains pork gelatine.
Simethicone may reduce the bioavailability of other drugs taken at the same time. If other drugs are to be used concurrently with the medical device, make sure there is a gap at least one hour before taking the medical device and other products. If in doubt, consult your doctor or pharmacist. In case of simultaneous use of levothyroxine and simethicone, a 4-hour interval should be observed.
OTHER
OTHER
OTHER
OTHER
Do not use the device after the expiry date which is stated on the blister and the carton box.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Poland; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Jun 1, 2020 | Still on market |
| Czechia | Jun 1, 2020 | Still on market |
| Italy | Mar 1, 2025 | Still on market |
| Romania | Jun 1, 2020 | Still on market |
| Slovakia | Jun 1, 2020 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-M012FABasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-M012FAM012UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
V0299NEONATOLOGY AND PAEDIATRIC DEVICES - OTHERG0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERSNo certificate specifically references this device's Basic UDI-DI.
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.