A1-05R2-1

Organization name

ASFALIS

SRN

FR-MF-000003046

Manufacturer status

Active

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

• CW027

  Though the device do not contain magnetizable materials, its use in MRI room is not advisable. Such a use can cause induced currents in the cable (due to their length) that could harm the patient.
• CW032

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

  Electrodes should be applied only to intact, clean skin (not over lesions, infected or inflamed areas)
• CW999

  During surgical procedures, electrodes and lead wires should be placed as far as possible from the electro-surgical area to minimize unwanted RF current flow and potential burns.
• CW999

  Electrodes dry out in an opened pouch. Do not open pouch until necessary. The device should be used within 24 hours of its opening. Do not use if gel dried out.
• CW009

  The device is disposable and must not be used with several patients
• CW010

  check IFU for detailed description of warnings and cautions

Primary placement in Germany; available across 4 countries total.

Trade name

not provided

UDI-DI code

03760286540108

Basic UDI-DI

3760286540235035DP

Reference / catalog number

A1-05R2-1

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Radio-transparent disposable ECG electrodes lead set with 5 pre-wired electrodes for Chest leads V2, V3, V4, V5 and V6

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• C020501ECG ELECTRODES

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