- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jan 21, 2026
9556564-NMCM-U4Mister Size Size 57 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Karex Industries Sdn. Bhd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04260605480607BULK571000MS(01)04260605480607
European Medical Device Nomenclature — the EU product classification assigned to this device.
U110101CONDOMS5 warnings recorded — scroll inside the panel to see all entries.
This product contains natural rubber latex which may cause allergic reactions including anaphylactic shock. If you are allergic to natural rubber latex products, consult your doctor for advice before use
Consult a doctor or pharmacist about the compatibility of topical medicines that are applied to the penis or vagina and might come in contact with the condom, as these may also damage the condom
Read carefully the instructions before use
Condoms are for single use only; reused condom could increase the risk of breakage and infection.
Do not use the condom if the rubber materials are sticky or brittle. If the individual container is obviously damaged, discard that condom and use a new one from an undamaged package.
MY-MF-000001247The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Denmark | — | Still on market |
| France | — | Still on market |
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 →Certificate health across this manufacturer's portfolio.
G10 102558 0008IssuedNotified 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.
No certificate specifically references this device's Basic UDI-DI.