Organization name

İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.

SRN

TR-MF-000019963

Manufacturer status

Active

D-8683498152332EN

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

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

Primary placement in Türkiye; available across 32 countries total.

Trade name

EXTENDER

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.

D-8683498152332EN

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-8683498152332EN

Reference / catalog number

LPOTW60220S

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.

EUDAMED

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.

• C010402020101PTA BALLOON DILATATION CATHETERS

• Class III medical devices in EUDAMED

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