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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

CT28089 — Class IIb MDR by Omega Pharma…

MD Atlas
Omega Pharma International NV

EUDAMED last updated this device on May 18, 2026

CT28089

5400951FBFORTIIBT2B5

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Omega Pharma International NV
UDI-DI code: 05400951001197
Reference / catalog number: CT28089

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Manufacturer information

Organization name: Omega Pharma International NV
SRN: BE-MF-000007210
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Oct 21, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05400951001197
Basic UDI-DI: 5400951FBFORTIIBT2B5
Reference / catalog number: CT28089
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G0402ORALLY ADMINISTERED DEVICES FOR APPETITE CONTROL AND REDUCTION OF INTESTINAL ABSORPTION

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

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.