Organization name

Conmed Corporation

SRN

US-MF-000012663

Manufacturer status

Active

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

6 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.
• CW017

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

  Ag/AgCl

Primary placement in Belgium; available across 29 countries total.

Trade name

EXACTRACE

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.

10653405003694

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.

084585408541DB

Reference / catalog number

1510-030

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

600

Additional product description

EXACTRACE ADULT ECG 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.

• C020501ECG ELECTRODES

• Class I medical devices in EUDAMED