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EUDAMED last updated this device on Aug 7, 2024
B-06972985351221Disposable Guide Wire is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Ortus Medi-Tech Co.,Ltd. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06972985351221OM-GW-P21150SCN-MF-000031033G2 102184 0004(01)06972985351221
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 6 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
C04030102DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILICPrimary 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.
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.B-06972985352150On the marketDisposable Guide WireB-06972985352112On the marketDisposable Guide WireB-06972985351276On the marketDisposable Guide WireB-06972985351191On the marketDisposable Guide WireB-06972985352273On the marketDisposable Guide WireB-06972985352310On the market