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EUDAMED last updated this device on Aug 26, 2022
B-BM004RMPorost islandzki – syrop is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. 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.
PL-MF-000007127D-BM004RM
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
5 warnings recorded — scroll inside the panel to see all entries.
The product can be used by pregnant women and during breastfeeding after consulting a doctor. The use of the product in children under 1 year of age should be consulted with a doctor. If in doubt, contact your doctor or pharmacist.
Use only in accordance with the instructions for use.
If symptoms persist or worsen after 7 days, consult your doctor or pharmacist.
Keep out of the reach and sight of children.
Due to the content of sucrose (810 mg/ 5ml) caution is recommended in diabetic patients. May have a laxative effect if used too much in children. Do not use in case of allergy or hypersensitivity to any of the ingredients of the product.
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 2 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | May 19, 2021 | Still on market |
| Slovakia | May 19, 2021 | 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-BM004RMBasic 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-BM004RMBM004UDI 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.
V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No 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.