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EUDAMED last updated this device on Apr 15, 2022
854137001MPNKLexofin Micro CE, 0.5g is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Chemence Medical Inc.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000000888No 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.(01)00854137001276
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
Consult instructions for use for warnings and contraindications
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 Poland; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Jan 10, 2020 | Jan 1, 2029 |
| Czechia | Jan 10, 2020 | Jan 1, 2029 |
| EL | Feb 4, 2020 | Jan 1, 2029 |
| Spain | Jan 10, 2020 | Jan 1, 2029 |
| Finland | Sep 29, 2021 | Jan 1, 2029 |
| France | Mar 4, 2021 | Jan 1, 2029 |
| Italy | Jan 10, 2020 | Jan 1, 2029 |
| Lithuania | Feb 28, 2020 | Jan 1, 2029 |
| Sweden | Jun 4, 2021 | Jan 1, 2029 |
| Türkiye | Jul 21, 2020 | Jan 1, 2029 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00854137001276Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
854137001MPNKLEX91510UDI 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.
2 packaging levels registered — each level carries its own UDI-DI.
00854137001276× 1 unitBase unit00854137001283× 10 units00854137001290× 6 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
H900199TISSUE ADHESIVES - OTHERPrimary 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.
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