Organization name

FG GRUP SAĞLIK İNŞAAT HARİTA MİMARLIK MÜHENDİSLİK ELEKTRONİK SANAYİ VE TİCARET ANONİM ŞİRKETİ

SRN

TR-MF-000027182

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• Do not re-use
• Consult instructions for use
• Do not use if package is damaged
• Do not resterilize

Primary placement in Türkiye; available across 32 countries total.

Trade name

BIOLAS Variclose Set Kuru Hava 10 (Variclose Set Dry 10)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08680400439918

Basic UDI-DI

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.

B-08680400439918

Reference / catalog number

CA0219

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• H90010102SYNTHETIC GLUES

• Class III medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.