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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

CT28086 — Class IIb MDR by Omega Pharma…

MD Atlas
Omega Pharma International NV

EUDAMED last updated this device on May 18, 2026

CT28086

5400951FBFORTIIBT1B3

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Omega Pharma International NV
UDI-DI code: 08470002055292
Reference / catalog number: CT28086

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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 Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08470002055292
Basic UDI-DI: 5400951FBFORTIIBT1B3
Reference / catalog number: CT28086
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

Related devices

CT299765400951PARSHAMPACZFOn the market CT321605400951PARSHAMPBCZJOn the market CT265715400951PARSHAMPBCZJOn the market CT300305400951PARTREATSHAMPC3TOn the market CT280885400951FBFORTIIBT1B3On the market

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.