Tucuvi Health Manager

Organization name

Tucuvi Care, S.L

SRN

ES-MF-000033271

Manufacturer status

Active

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

• CW999

  While Tucuvi Health Manager is highly adaptable, it is not recommended for use with patients who have severe speech or hearing impairments, or severe mental disorders unless the protocols are specifically tailored to accommodate these patients. This ensures that all patient interactions through the software are effective and sensitive to the specific needs of the patient population.
• CW999

  A dependency and assumption for the safe intended use of THM are that Tucuvi Health Manager is not intended by Tucuvi to be used in place of expert clinical judgement and decision-making. Clinicians should always use clinical judgement when determining patient suitability for the product.

Primary placement in Spain; available across 2 countries total.

Trade name

Tucuvi Health Manager

UDI-DI code

08437025518005

Basic UDI-DI

8437025518THMCK

Reference / catalog number

THM

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

This device is not currently linked to any other device.

Certificate health across this manufacturer's portfolio.