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EUDAMED last updated this device on May 18, 2026
5400951FBFORTIIBT1B3XLS Medical Pro 7 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Omega Pharma International NV. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05400951001180CT28088(01)05400951001180
European Medical Device Nomenclature — the EU product classification assigned to this device.
G0402ORALLY ADMINISTERED DEVICES FOR APPETITE CONTROL AND REDUCTION OF INTESTINAL ABSORPTION1 warning recorded — scroll inside the panel to see all entries.
Only recommended for adults over 18 years of age. Do not take XLS MEDICAL PRO-7: - during pregnancy or whilst breastfeeding; - if your BMI (Body Mass Index) is below 18,5 (it is recommended to check your BMI during use); - if you are allergic to any of the ingredients listed.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Oct 21, 2024 | Still on market |
BE-MF-000007210The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
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Certificate health across this manufacturer's portfolio.
20311GB448260506SupplementedNotified 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.
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