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US-MF-000020031CE 00340SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Cordis US Corp.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 17, 2026
B-20705032079577Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)20705032079577
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 Netherlands; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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.
20705032079577Basic 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-2070503207957748004006RUDI 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.
C010402020101PTA BALLOON DILATATION CATHETERS07050320000000000000012C8On the marketRAIN Sheath™ Transradial Introducer07050320000000000000068D3On the marketRAIN Sheath™ Transradial Introducer07050320000000000000068D3On the marketSABER™ .035 Percutaneous Transluminal
Angioplasty (PTA) Dilatation CatheterB-20705032081150On the marketSABER™ .035 Percutaneous Transluminal
Angioplasty (PTA) Dilatation CatheterB-20705032080450On the marketSABER™ .035 Percutaneous Transluminal
Angioplasty (PTA) Dilatation CatheterB-20705032080948On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
MDR 771921SupplementedMDR 771922SupplementedMDR 771918SupplementedNotified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →