S24817

Organization name

Detalo Health ApS

SRN

DK-MF-000035616

Manufacturer status

Active

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

• CW018

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW011

  The Detalo Clinical may not be used in the following conditions and populations: • Pregnancy. • Patients under the age of 18 years. • Patients with a pre-measurement carboxyhaemoglobin percentage (%HbCO) over 1.5%. • Patients who are not conscious or otherwise unable to perform rebreathing.
• CW016

  EUDAMED did not publish a description for this code.

Primary placement in Denmark; available across 5 countries total.

Trade name

not provided

UDI-DI code

05700002267610

Basic UDI-DI

57000022676DC-CSERIES01ML

Reference / catalog number

S24817

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The intended use of the Detalo Clinical device is to facilitate CO rebreathing with the purpose to quantify haemoglobin mass (Hbmass), red blood cell volume (RBCV), plasma volume (PV) and total blood volume (BV).

Additional information URL

https://detalo-health.com/IFU

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.

• V0399MEASUREMENT DEVICES - OTHER