REALICA DENTAL SEDATION

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 9 countries total.

Trade name

REALICA DENTAL SEDATION

UDI-DI code

08053295450014

Basic UDI-DI

805329545REALICAVRJ5

Reference / catalog number

RE.112303

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 DENTAL SEDATION is an immersive virtual reality system designed to improve the management of pain, stress, and anxiety in dental patients. It offers a non-pharmacological or complementary alternative to traditional drug-based treatments or sedative gases, with the aim of enhancing patient comfort and emotional well-being during dental 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