- Role
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IT-MF-000025581SIARETRON 1000 IPER is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Siare Enginnering International Group S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 19, 2026
80337372632Q2Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08033737263204
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.
The lung ventilator shall not be used with nitric oxide. Do not block the gas intake port or emergency intake port, thereby interfering with PATIENT ventilation. The medical device is suitable for operation in a hyperbaric chamber up to a maximum internal pressure of 6 bar.
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 Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Feb 20, 2024 | Dec 31, 2099 |
| Austria | Feb 20, 2024 | Dec 31, 2099 |
| Belgium | Feb 20, 2024 | Dec 31, 2099 |
| Bulgaria | Feb 20, 2024 | Dec 31, 2099 |
| Cyprus | Feb 20, 2024 | Dec 31, 2099 |
| Czechia | Feb 20, 2024 | Dec 31, 2099 |
| Germany | Feb 20, 2024 | Dec 31, 2099 |
| Denmark | Feb 20, 2024 | Dec 31, 2099 |
| Estonia | Feb 20, 2024 | Dec 31, 2099 |
| EL | Feb 20, 2024 | Dec 31, 2099 |
| Spain | Feb 20, 2024 | Dec 31, 2099 |
| Finland | Feb 20, 2024 | Dec 31, 2099 |
| France | Feb 20, 2024 | Dec 31, 2099 |
| Croatia | Feb 20, 2024 | Dec 31, 2099 |
| Hungary | Feb 20, 2024 | Dec 31, 2099 |
| Ireland | Feb 20, 2024 | Dec 31, 2099 |
| Iceland | Feb 20, 2024 | Dec 31, 2099 |
| Liechtenstein | Feb 20, 2024 | Dec 31, 2099 |
| Lithuania | Feb 20, 2024 | Dec 31, 2099 |
| Luxembourg | Feb 20, 2024 | Dec 31, 2099 |
| Latvia | Feb 20, 2024 | Dec 31, 2099 |
| Malta | Feb 20, 2024 | Dec 31, 2099 |
| Netherlands | Feb 20, 2024 | Dec 31, 2099 |
| Norway | Feb 20, 2024 | Dec 31, 2099 |
| Poland | Feb 20, 2024 | Dec 31, 2099 |
| Portugal | Feb 20, 2024 | Dec 31, 2099 |
| Romania | Feb 20, 2024 | Dec 31, 2099 |
| Sweden | Feb 20, 2024 | Dec 31, 2099 |
| Slovenia | Feb 20, 2024 | Dec 31, 2099 |
| Slovakia | Feb 20, 2024 | Dec 31, 2099 |
| Türkiye | Feb 20, 2024 | Dec 31, 2099 |
| XI | Feb 20, 2024 | Dec 31, 2099 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08033737263204Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
80337372632Q2960104UDI 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.
Z1203010504ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORSNo certificate specifically references this device's Basic UDI-DI.
No 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.