Organization name

EMED SP. Z O. O. SP. K.

SRN

PL-MF-000012648

Manufacturer status

Active

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

1 warning recorded — scroll inside the panel to see all entries.

• Caution

  See IFU

Primary placement in Poland; available across 2 countries total.

Trade name

Monopolar cable for argon flexible electrode, flat connector, L: 3.5m, SDSA plug

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.

05907763204483

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.

59077632-TF21CABLE-DL

Reference / catalog number

432-46A

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

For the transmission of energy and argon gas between the active device and the patient – without any significant changes – for the purpose of monopolar tissue coagulation using argon plasma in electrosurgery.

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.

• L181003ELECTROSURGERY CONNECTION CABLES, REUSABLE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.