- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jul 27, 2026
871830970M6X0EGEAPirolam Derm Leczenie grzybicy paznokcia - 4mL Pen is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Serrix B.V. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08718309703493M630PL(01)08718309703493
European Medical Device Nomenclature — the EU product classification assigned to this device.
M0410DRESSINGS FOR NAILS IN THE FORM OF LIQUIDS, GELS AND CREAMS3 warnings recorded — scroll inside the panel to see all entries.
When pregnant or breastfeeding, consult a health care professional before use.
Consult instruction for use (symbol)
Single patient, multiple use (symbol)
NL-MF-000005882The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | 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 →No certificate specifically references this device's Basic UDI-DI.
871830970M0X0EGC8On the marketMycosana Unhas Fungos das Unhas Kit de tratamento - 5mL Brushtube871830970M0X0EGC8On the marketNormolabial Tratamiemento para el herpes labial - 6 mL Tube871830970L0X0EGBTOn the marketPirolam Derm Leczenie grzybicy paznokcia + kamuflaż - 5mL Jar + 8mL NailPolish871830970M6X0EGEAOn the marketPirolam Derm Leczenie grzybicy stóp - 15 mL Brushtube871830970M2X0EGCWOn the marketSoreFix Ehkäisevä Huuliherpesvoide - 8 mL Jar871830970L0X0EGBTOn the marketCertificate health across this manufacturer's portfolio.
BE23/00000172SupplementedNotified 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 →