RVer is registered in EUDAMED. What changes, and what does not

On 10 October 2026, the RVer base product, the video library, was registered in EUDAMED, the European database on medical devices. It is now a Class I medical device, CE marked (MDR 2017/745), registered in EUDAMED and with INFARMED (Portugal).

Here is what that means, without overstating or understating it.

The numbers

These are the identifiers of the registration, as listed in EUDAMED:

• Basic UDI-DI: 56006195127RVERTZ, which identifies the device model.
• UDI-DI: 05600619512700, the same one already on the label.
• Manufacturer: Amplified Creations - Informática e Gestão, Lda., with SRN PT-MF-000059840.
• Status: Registered.

The INFARMED registration stays in place, with the same number as always: CDM 94571546.

What EUDAMED is

EUDAMED is the European database on medical devices set up under Regulation (EU) 2017/745. It brings together, in one place, information on economic operators, devices and vigilance, and it is designed to make the European medical device market more transparent and traceable.

Registering devices in EUDAMED became mandatory on 28 May 2026. Devices already on the market had until 28 November 2026 to do so.

Why we say EUDAMED and INFARMED

It may look redundant, but these are two different registrations, each with its own number.

• EUDAMED (Basic UDI-DI 56006195127RVERTZ) is the European registration. It is what makes sense to anyone outside Portugal who does not know INFARMED.
• INFARMED (CDM 94571546) is the national registration, with the Portuguese competent authority for medical devices. It is what a Portuguese tender panel or clinical board recognises straight away.

INFARMED also plays a part in EUDAMED: it was INFARMED that assigned the manufacturer its SRN, when it registered as an economic operator. But EUDAMED does not replace the national registration, and the INFARMED CDM number is not a EUDAMED number. That is why we name both.

What changes for buyers

Little in day-to-day use, and that is a good sign: the product is the same. What changes is how easy it is to check.

• Anyone can confirm the registration, without asking us, on the public EUDAMED portal, by Basic UDI-DI or by manufacturer name.
• In a tender specification, where the device registration number is requested, there are now two to give: the INFARMED CDM and the EUDAMED Basic UDI-DI.
• The identifiers match across the label, the manual, the app (which shows the full UDI in the footer of the main screen) and EUDAMED.

What does not change

• The class. It is still a Class I medical device, the lowest-risk class, CE marked under MDR 2017/745.
• The scope. The registration covers the base product: the video library. RVer Motion, RVer Neuro and RVer Exposure are modules in development and are not covered by the Class I medical device registration.
• What RVer is. A non-pharmacological complement for comfort, distraction, guided activity and wellbeing, always under the supervision of the healthcare team. It does not treat, does not diagnose and does not replace medical care. No registration changes that, and we do not want it to look as if it does.

Where to find it all in writing

The numbers are on the science and regulation page, in the documents list of the procurement dossier and in the user manual. If you need them in a particular format for a procurement process, write to us.