- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Nov 14, 2025
B-19555012422749Beltex XL is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by PLEASURE LATEX PRODUCTS SDN. BHD.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
19555012422749BTXL144(01)19555012422749
European Medical Device Nomenclature — the EU product classification assigned to this device.
U110101CONDOMS13 warnings recorded — scroll inside the panel to see all entries.
If you and your partner are using any medication in the genital area, consult your doctor or pharmacist that it is safe to use with the condoms.
Caution: This condom is made of natural rubber latex which might cause allergic reactions including anaphylactic shock.
If you and your partner are using any medication in the genital area, consult your doctor or pharmacist that it is safe to use with the condoms.
Do not reuse as there might be an increased risk of failure or infection.
Primary placement in Belgium; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
MY-MF-0000161997536GB410210512AIf the individual container is obviously damaged, discard the condom and use a new one from an undamaged package.
Keep away from children.
OTHER
OTHER
OTHER
OTHER
OTHER
OTHER
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.
Certificate health across this manufacturer's portfolio.
7536GB448260126SupplementedNotified 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 →