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The facts about RVer, ready to copy, worded the way the device registration allows.

Full kit (.zip)

01The 30-second summary

What it isVirtual reality for clinical use

A non-pharmacological complement, under the supervision of the healthcare team.

RegistrationClass I · Infarmed

Base product · CDM 94571546 · CE marking

Who makes itAmplified Creations, Lda.

Leiria, Portugal · since 2021

02Description

One line · EN

RVer is a virtual reality system for assisted clinical use, developed in Leiria, Portugal, by Amplified Creations, Lda.

Paragraph · EN

RVer is a virtual reality system for assisted clinical use, used in hospitals, clinics and care homes as a non-pharmacological complement for comfort, distraction, guided activity and wellbeing, always under the supervision of the healthcare team. Its base product, the video library, is registered as a Class I Medical Device with Infarmed (no. CDM 94571546), CE-marked under MDR 2017/745. RVer is a brand of Amplified Creations, Lda., based in Leiria, Portugal.

03Fact sheet

Brand: RVer
Company: Amplified Creations, Lda.
Founded: 2021
Headquarters: Leiria, Portugal · office in Lisbon
Registration: Class I Medical Device (base product) · Infarmed, no. CDM 94571546 · CE marking under MDR 2017/745, self-declared by the manufacturer
Where it is used: Hospitals, clinics, care homes and palliative care in Portugal · partner in Brazil (Instituto Gabriel Benício)
Modules: RVer Motion, RVer Neuro and RVer Exposure: in development, not covered by the registration
Website: rver.pt

04How to describe RVer

RVer is a medical device, and how it is described has regulatory consequences. Here is what matches the registration and what does not.

You can write

“non-pharmacological complement”
“comfort and distraction during procedures”
“always under the supervision of the healthcare team”
“Class I medical device (base product)”
“virtual reality for clinical use”

Avoid — and why

“treats”, “cures”, “therapy that replaces…”RVer complements care; it does not replace it.
“reduces pain” or any other clinical effectit is not a claim of the device.
“diagnoses”, “assesses”, “measures”the system does not assess or diagnose.
“approved by Infarmed”a Class I device is registered by the manufacturer, not approved.
“the modules are certified”Motion, Neuro and Exposure are not covered by the registration.