- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 7, 2026
B-08681299208043OPTIMA-II DUAL LUMEN LONG TERM CATHETER SET 14Fr 55 Cm PRE-CURVED 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 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.(01)08681299208043
4 warnings recorded — scroll inside the panel to see all entries.
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 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.
08681299208043Basic 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-08681299208043DDLC-1455-SPVUDI 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-08681299207886On the marketOPTIMA-II DUAL LUMEN LONG TERM CATHETER SET 14Fr 40 Cm PRE-CURVEDB-08681299208036On the marketOPTIMA-II DUAL LUMEN LONG TERM CATHETER SET 14Fr 40 Cm STRAIGHTB-08681299207893On the marketOPTIMA-II DUAL LUMEN LONG TERM CATHETER SET 14Fr 55 Cm STRAIGHTB-08681299207909On the marketOPTIMA-II DUAL LUMEN LONG TERM CATHETER SET 16Fr 24 Cm PRE-CURVEDB-08681299208050On the marketOPTIMA-II DUAL LUMEN LONG TERM CATHETER SET 16Fr 24 Cm STRAIGHTB-08681299207916On the market