Redsense Alarm unit with FOE, IFU, charger EU

Organization name

Redsense Medical AB

SRN

SE-MF-000005240

Manufacturer status

Active

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

• CW013

  Class I laser product
• CW010

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• CW007

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• CW136

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• CW168

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• CW027

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• CW135

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Primary placement in Netherlands; available across 10 countries total.

Trade name

Redsense Alarm unit with FOE, IFU, charger EU

UDI-DI code

07350078030021

Basic UDI-DI

7350078030021VY

Reference / catalog number

RA-1-RA201-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 Alarm System is intended to monitor for potential blood loss from the hemodialysis access site in patients undergoing hemodialysis treatment.

Additional information URL

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

Clinical sizes

• Alarm unit: 128 x 100 x 35 mm. FOE: 2 meters long and 15 milimeter in diameter in the widest place. EU charger: 55 x 41 x 31 mm, with the cord 3000 mm x 10 mm.
• Alarm unit: 150 grams. FOE: 32 grams. EU charger: 161 grams.

• 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