Organization name

EUROCOSMETIC s.r.l.

SRN

RO-MF-000000906

Manufacturer status

Active

Primary placement in Hungary; available across 32 countries total.

Trade name

IZIS FIX CLASSIC Rugalmas pólya 14 cm x 5 m (egyenként csomagolt)

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.

05940741461355

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.

594074146ELBANDCM

Reference / catalog number

C14550

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 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

• 5 MU36
• 14 MU10

1 packaging level registered — each level carries its own UDI-DI.

• 05940741461355× 1 unitBase unit
  • 05940741461461× 50 units

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

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

• M030402010101ELASTIC SUPPORT BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY

• Class I medical devices in EUDAMED

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