Redsense Alarm system EU charger

Organization name

Redsense Medical AB

SRN

SE-MF-000005240

Manufacturer status

Active

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

• CW010

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

  Do not use if cracked or cable damaged
• CW168

  EUDAMED did not publish a description for this code.
• CW027

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

  EUDAMED did not publish a description for this code.
• CW134

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW136

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 10 countries total.

Trade name

Redsense Alarm system EU charger

UDI-DI code

07350078030113

Basic UDI-DI

7350078030113W6

Reference / catalog number

RC-1-RC201-A

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

The Redsense EU charger is intended to be used in order to connect and charger the Redsense Alarm System. It is part of the system to monitor for potential blood loss from the hemodialysis access site in patients undergoing hemodialysis treatment and should not be used separately or for any other purpose.

Additional information URL

https://redsensemedical.com/training-education/instruction-guides/Redsense%20Alarm%20system%20CE%20charger

Clinical sizes

• 161 MU24
• 55 x 41 x 31 mm, with the cord 3000 mm x 6 mm.

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

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

• F9099DIALYSIS DEVICES - OTHER