REALICA BABE

Organization name

VALIAMO SRL

SRN

IT-MF-000014882

Manufacturer status

Active

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

• CW261

  should not be used on patients : - under 7 years of age - psychotic patients and patients diagnosed with psychiatric disorders - with unbalanced epilepsy - with visual (lack of binocular vision) and/or auditory (deafness, blindness) disorders that prevent the use of virtual reality.
• CW260

  Non deve essere utilizzato su pazienti: di età inferiore ai 7 anni psicotici o con diagnosi di disturbi psichiatrici affetti da epilessia non controllata con disturbi visivi (assenza di visione binoculare) e/o uditivi (sordità, cecità) che impediscono l’utilizzo della realtà virtuale

Primary placement in Italy; available across 8 countries total.

Trade name

REALICA BABE

UDI-DI code

08053295450021

Basic UDI-DI

805329545REALICAVRJ5

Reference / catalog number

RE.112302

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

REALICA BABE is an immersive virtual reality system designed to enhance the management of pain, stress, and anxiety in patients. It provides a non-pharmacological or complementary alternative to traditional drug-based treatments, aiming to improve patient comfort and emotional well-being during medical procedures.

Additional information URL

https://realica.it/

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.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES