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EUDAMED last updated this device on Nov 14, 2025
B-09555012422940Climax Change Smooth Solution For A Tough Problem is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by PLEASURE LATEX PRODUCTS SDN. BHD.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
09555012422940CCPL120(01)09555012422940
MY-MF-0000161997536GB414210512A9 warnings recorded — scroll inside the panel to see all entries.
If irritation or discomfort occurs, discontinue use and consult your doctor.
Keep out of reach of children.
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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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)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 →B-19555012422923On the marketClimax Change SmoothB-19555012422916On the marketClimax Change SmoothB-19555012422930On the marketClimax Change Ultra ThinB-19555012422787On the marketClimax Change Ultra ThinB-19555012422770On the marketClimax Change Ultra ThinB-19555012422763On the marketNo 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 →