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EUDAMED last updated this device on May 26, 2023
B-08055186671041PRIMAX INTERNATIONAL HIRIS RF43-TS is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by A.T.S. Applicazione Tecnologie Speciali s.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0805518667104190 01 000(01)08055186671041
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z119007IMAGE ACQUISITION MODULES1 warning recorded — scroll inside the panel to see all entries.
CW010IT-MF-0000107341074/MDDPrimary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Mar 5, 2020 | 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-08055186670570On the marketPRIMAX INTERNATIONAL CYBERBLOC FP-SB-08055186670563On the marketPRIMAX INTERNATIONAL CYBERBLOC FP-SB-08055186670587On the marketPRIMAX International Primo-WB-08055186671072On the marketRADIOLOGIA OMNISCOP FPB-08055186670624On the marketRADIOLOGIA OMNISCOP FPB-08055186670617On the marketCertificate health across this manufacturer's portfolio.
ITH 2492603 1SupplementedNotified 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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