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EUDAMED last updated this device on Aug 30, 2026
8411134CDLB001AFCONTROL Ultrafeel BX10 Es-It-Pt Hang Tab is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Tecnilatex, S.A.U.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
084111341469223010071 packaging level registered — each level carries its own UDI-DI.
08411134146922× 10 unitsBase unit28411134146926× 6 units(01)08411134146922
European Medical Device Nomenclature — the EU product classification assigned to this device.
U110101CONDOMS9 warnings recorded — scroll inside the panel to see all entries.
If you want additional lubrication, use a suitable lubricant, recommended for use with condoms and avoid using oily lubricants such as petroleum jelly, baby oil, body lotions, massage oils, butter, margarine, etc. that can alter the integrity of the condom.
Some medication or topical products applied to the intimate areas can damage condoms, so always check with a doctor or a pharmacist.
It is a natural rubber latex condom. The latex might cause allergy reactions including anaphylactic shock if the user is allergic to latex.
OTHER
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
ES-MF-000000284The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
OTHER
Use a new condom in each sex act or if you change partners during intercourse. It is a single-use product. Its reuse increases the risk of failure, and therefore, of pregnancy and infection.
Check the condom wrapper and its expiration date, and if it is visibly damaged, discard it and use a new one that is in perfect condition.
Check the condom wrapper and its expiration date
For your protection, it is important to read the instructions on the inside of the pack.
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 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.No certificate specifically references this device's Basic UDI-DI.
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