- Organization name
- UDI-DI code
- Reference / catalog number
TR-MF-000027182M.2013.106.2573-1 M.2013.106.2573-1 BIOLAS Variclose uygulama kateteri ile birlikte set I is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by FG GRUP SAĞLIK İNŞAAT HARİTA MİMARLIK MÜHENDİSLİK ELEKTRONİK SANAYİ VE TİCARET ANONİM ŞİRKETİ. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 15, 2026
B-08680400436924Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08680400436924
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 32 countries total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary 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 |
| Netherlands | — | 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 |
| 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.
08680400436924Basic 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-08680400436924CA0141UDI 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.
H90010102SYNTHETIC GLUESNo certificate specifically references this device's Basic UDI-DI.
B-08680400439871On the marketBIOLAS Variclose Set Kuru Hava 10 (Variclose Set Dry 10)B-08680400439918On the marketBIOLAS Variclose Set Kuru Hava 2 (Variclose Set Dry 2)B-08680400439888On the marketBIOLAS Variclose uygulama kateteri ile birlikte set IIB-08680400436931On the marketBIOLAS Variclose uygulama kateteri ile birlikte set IIIB-08680400436948On the marketBIOLAS Variclose uygulama kateteri ile birlikte set VB-08680400436962On 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.