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EUDAMED last updated this device on Sep 18, 2024
B-590376950212779UCHOLEK HIGIENA Spray do usuwania woskowiny usznej is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Gofarm Sp. z o.o. Sp. k.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-590376950212779ENT07D-590376950212779
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q03040201EAR DROPPERS4 warnings recorded — scroll inside the panel to see all entries.
Nie należy stosować wyrobu po upływie daty ważności umieszczonej na opakowaniu.
Nie stosować w przypadku uszkodzenia opakowania bezpośredniego.
Spray do higieny uszu należy używać wyłącznie do użytku zewnętrznego zgodnie z instrukcją używania.
OTHER
PL-MF-0000034851434-MDD-326/2020Primary 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.
B-59037695018858KOn the marketSilConil żel na blizny5906395089SC079WOn the marketSpray do higieny uszu (Zyskaj zdrowie)B-59037695019227YOn the marketVagi-Guard EasyB-59037695007037BOn the marketVagysoftB-590376950045177On the marketVivo Ear DropsB-4897082940180CAOn the marketCertificate health across this manufacturer's portfolio.
1434-MDR-006/2026IssuedNotified 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.
1434-MDR-046/2025IssuedNotified 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.
1434-MDR-045/2025IssuedNotified 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.
1434-MDR-044/2025IssuedNotified 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.
1434-MDR-042/2025IssuedNotified 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.
1434-MDR-041/2025SupplementedNotified 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 →