Organization name

Conmed Corporation

SRN

US-MF-000012663

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Age/Weight Range: > 15 kg

Primary placement in Belgium; available across 31 countries total.

Trade name

MACROLYTE

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.

30653405007016

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-30653405007016

Reference / catalog number

400-2700

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

MACROLYTE DISPERSIVE ELECTRODE

Additional information URL

https://eifu.conmed.com/eifu/

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.

• K02010201ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE

• Class IIb medical devices in EUDAMED

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