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PL-MF-000018645elmex Sensitive Plus Repair & Prevent is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Colgate-Palmolive Manufacturing (Poland) sp. z o.o.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 9, 2023
590900088506ColgateTPVQPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08718951462380
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Romania; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| France | — | Still on market |
| Luxembourg | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08718951462380Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
590900088506ColgateTPVQ61032848UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q019008DENTINAL DESENSITISERSNo 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.590900088506ColgateTPVQOn the marketColgate® Sensitive Repair & Prevent + Gentle Whitening590900088506ColgateTPVQOn the marketColgate® Sensitive Repair & Prevent + Multi Protection590900088506ColgateTPVQOn the marketelmex Sensitive Plus REPAIR & PREVENT590900088506ColgateTPVQOn the marketelmex Sensitive Professional590900088506ColgateTPVQOn the marketelmex Sensitive Professional590900088506ColgateTPVQOn the marketNo certificate specifically references this device's Basic UDI-DI.