- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 26, 2026
B-08681299260621HIGHSTREAM –II SPLIT DUAL LUMEN LONG TERM CATHETER SET 12Fr 36Cm STRAIGHT is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by DLR Medikal. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
TR-MF-000024447M.2016.106.7244 (01)08681299260621
4 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW001CW007Sterile
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 Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | — | 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.
08681299260621Basic 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-08681299260621HSSC-1236-SVUDI 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.
F900202PERMANENT HEMODIALYSIS CATHETERS AND KITSPrimary 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-08681299260652On the marketHIGHSTREAM –II SPLIT DUAL LUMEN LONG TERM CATHETER SET 12Fr 32Cm STRAIGHTB-08681299260614On the marketHIGHSTREAM –II SPLIT DUAL LUMEN LONG TERM CATHETER SET 12Fr 36 Cm PRE-CURVEDB-08681299260669On the marketHIGHSTREAM –II SPLIT DUAL LUMEN LONG TERM CATHETER SET 12Fr 40Cm PRE-CURVEDB-08681299260676On the marketHIGHSTREAM –II SPLIT DUAL LUMEN LONG TERM CATHETER SET 12Fr 40Cm STRAIGHTB-08681299260638On the marketHIGHSTREAM –II SPLIT DUAL LUMEN LONG TERM CATHETER SET 14,5Fr 24Cm PRE-CURVEDB-08681299215188On the marketNo 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.