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US-MF-00000987841376908SecurAcath is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Interrad Medical, Inc.. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Sep 26, 2022
B-00865382000297Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00865382000297
3 warnings recorded — scroll inside the panel to see all entries.
Do not re-use. Intended for Single Patient. DO NOT REUSE. Reuse may lead to SAE and device malfunction.
After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice and applicable local, state and federal laws and regulations
Contains Nickel
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 XI; available across 28 countries total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | May 31, 2016 | Still on market |
| Austria | May 31, 2016 | Still on market |
| Belgium | May 31, 2016 | Still on market |
| Bulgaria | May 31, 2016 | Still on market |
| Cyprus | May 31, 2016 | Still on market |
| Czechia | May 31, 2016 | Still on market |
| Germany | May 31, 2016 | Still on market |
| Denmark | May 31, 2016 | Still on market |
| EL | May 31, 2016 | Still on market |
| Spain | May 31, 2016 | Still on market |
| Finland | May 31, 2016 | Still on market |
| France | May 31, 2016 | Still on market |
| Croatia | May 31, 2016 | Still on market |
| Ireland | May 31, 2016 | Still on market |
| Iceland | May 31, 2016 | Still on market |
| Italy | May 31, 2016 | Still on market |
| Liechtenstein | May 31, 2016 | Still on market |
| Luxembourg | May 31, 2016 | Still on market |
| Malta | May 31, 2016 | Still on market |
| Netherlands | May 31, 2016 | Still on market |
| Norway | May 31, 2016 | Still on market |
| Poland | May 31, 2016 | Still on market |
| Portugal | May 31, 2016 | Still on market |
| Romania | May 31, 2016 | Still on market |
| Sweden | May 31, 2016 | Still on market |
| Slovenia | May 31, 2016 | Still on market |
| Slovakia | May 31, 2016 | Still on market |
| Türkiye | May 31, 2016 | 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.
00865382000297Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-00865382000297400180UDI 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.
C010299CENTRAL VENOUS CATHETERS - OTHERC010180PERIPHERAL I.V. CATHETERS AND CANNULAS - ACCESSORIES NOT INCLUDED IN OTHER CLASSESV9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHERNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
28620239803IssuedNotified 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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