RE-1-RE201

Organization name

Redsense Medical AB

SRN

SE-MF-000005240

Manufacturer status

Active

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

• CW013

  Class I laser product.
• CW010

  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.
• CW139

  EUDAMED did not publish a description for this code.
• CW168

  EUDAMED did not publish a description for this code.
• CW030

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 10 countries total.

Trade name

not provided

UDI-DI code

07350078030441

Basic UDI-DI

7350078030441WS

Reference / catalog number

RE-1-RE201

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 fiber optics extension (FOE) is intended to be used in connection with the Alarm System, connecting the former and the sensor patch. It is part of the system to monitor for potential blood loss from the hemodialysis access site in patients undergoing hemodialysis treatment. This updated FOE improves ease, reliability and overall handling robustness.

Additional information URL

https://redsensemedical.com/training-education/instruction-guides/

Clinical sizes

• Alarm unit fiber optic extension weight 2 meters long and 15 millimeter in diameter in the widest place.
• 32 MU24

• 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