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EUDAMED last updated this device on Sep 10, 2026
5904335216zelsukralQ7MEDCARE Rectal Gel is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by LABORATOIRE L'IDEAL Parisien Sp. z o.o.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05906122471368MEDCARE Rectal Gel, 5 single-use applicators in a carton, twith instructions for use. Language version: English(01)05906122471368
European Medical Device Nomenclature — the EU product classification assigned to this device.
G05TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES8 warnings recorded — scroll inside the panel to see all entries.
Severe bleeding in cases of advanced hemorrhoids, occurring independently of bowel movements, is a situation in which you should contact a doctor. Use of the product in this situation is subject to a doctor’s decision. Pregnant women may use the medical device for up to 7 days. If longer use is required consult a doctor. • Due to its local mechanism of action and limited absorption of the substance, the product may be used for a short period (up to 7 days) in pregnant women. If longer use is necessary, consult a doctor.
Do not use the product if the outer packaging is damaged before first use. Do not use the product if the immediate packaging is damaged.
If symptoms do not subside or improve after using the product, consult a doctor.
Keep this product out of the reach of children.
PL-MF-000005402The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Before using this product, please read the instructions for use, as they contain important information for the patient regarding the use of the product. Keep the instructions for use so that you can refer to them again if necessary.
Store the product in its original packaging
OTHER
Do not use the medical device after the expiration date printed on the packaging.
Primary placement in Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
HZ 1554323-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
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