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EUDAMED last updated this device on Jul 28, 2025
5906188Dozowniki-kImPYDOZOWNIK STRZYKAWKOWY DO LEKÓW poj. 5ml STRZYKAWKA DOUSTNA 5ml (Podziałka 0,25ml-odwrócona) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
PL-MF-000015608(01)05906188005378
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 Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05906188005378Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5906188Dozowniki-kImPYQDOZ-0008-000UDI 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.
V0380DEVICES WITH MEASURING FUNCTIONS - ACCESSORIESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →5906188Dozowniki-kImPYOn the marketDOZOWNIK STRZYKAWKOWY DO LEKÓW poj. 5ml APLIKATOR 5ml HELIPICO5906188Dozowniki-kImPYOn the marketDOZOWNIK STRZYKAWKOWY DO LEKÓW poj. 5ml APLIKATOR 5ml HELIPICO5906188Dozowniki-kImPYOn the marketDOZOWNIK STRZYKAWKOWY DO LEKÓW poj. 5ml STRZYKAWKA DOUSTNA 5ml (Podziałka 0,25ml-odwrócona)5906188Dozowniki-kImPYOn the marketDOZOWNIK STRZYKAWKOWY DO LEKÓW poj. 5ml STRZYKAWKA DOUSTNA 5ml (Podziałka 0,25ml)5906188Dozowniki-kImPYOn the marketDOZOWNIK STRZYKAWKOWY DO LEKÓW poj. 5ml STRZYKAWKA DOUSTNA 5ml (Podziałka 0,25ml)5906188Dozowniki-kImPYOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
TNP/MDR/0024/0052/2024IssuedNotified 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.
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