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EUDAMED last updated this device on Jan 15, 2024
B-05012748605633MOVICOL® Plain is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Norgine BV. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0501274860563377710021 (10s carton)(01)05012748605633
European Medical Device Nomenclature — the EU product classification assigned to this device.
G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS8 warnings recorded — scroll inside the panel to see all entries.
OTHER
If you are pregnant, trying to become pregnant or breastfeeding, ask your pharmacist or doctor for advice before taking Movicol Plain.
There is a possibility that the absorption and consequently the effectiveness of any medicines taken orally could be reduced if taken at the same time as Movicol Plain. Therefore, as a precautionary measure, any medicines should not be taken orally for one hour before, during and for one hour after taking Movicol Plain. Please consult your doctor or pharmacist if you are taking, or have recently taken, any medicines, including medicines obtained without a prescription.
OTHER
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Oct 1, 2017 | Dec 31, 2028 |
NL-MF-000009565HD 1676230-1OTHER
OTHER
Keep out of the sight and reach of children.
Do not use Movicol Plain after the expiry date on the sachet. The expiry refers to the last day of the month.
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 →No certificate specifically references this device's Basic UDI-DI.
B-05012748605701On the marketMOVICOL® Paediatric PlainB-05012748605640On the marketMOVICOL® Paediatric PlainB-05012748606173On the marketMOVICOL® PlainB-05012748605657On the marketMOVICOL® Ready to TakeB-05012748606227On the marketMOVICOL® Ready to TakeB-05012748606234On the marketCertificate health across this manufacturer's portfolio.
HZ 1676230-1IssuedNotified 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 →