- Organization name
- UDI-DI code
- Reference / catalog number
PL-MF-000009272TNP/MDR/0038/4999/2025Systemy dystrybucji gazów medycznych do sprężonych gazów medycznych i próżni oraz do systemów usuwania gazów anestetycznych (AGSS) oraz instalacje zasilające i wyrzutowe do napędu pneumatycznych narzędzi chirurgicznych – seria PGAS is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Aug 21, 2025
590435882SRGMIIA2UPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05904358820073
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.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | 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.
05904358820073Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
590435882SRGMIIA2UPGASUDI 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.
Z120309MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES590435882SRGMM9On the marketSystem rurociagowy do gazów medycznych i próżni - SRGM-IIa590435882SRGMIIA2UOn the marketSystem rurociągowy do gazów medycznych i próżni - SRGM-IIb590435882SRGMM9On the marketSystemy zasilania butlowego wysokiego cisnienia do gazów medycznych - seria in.CYL590435882SRGMM9On the marketSystemy zasilania niskociśnieniowych zbiorników kriogenicznych - seria in.CRO590435882SRGMM9On the marketTablica poboru gazów - TPG-N590435882SRGMM9On the marketCertificate health across this manufacturer's portfolio.
TNP/MDR/0038/4999/2025IssuedNotified 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.
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