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Followhealth S.L.

Active in EUDAMED

Spainfrom SRN EUDAMED SRN ES-MF-000013991

Devices
2
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

Catalogue2

Newest first, rows 1-2 of 2

  • vitalera Ref vitalera v2.0

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb
  • humanITcare Ref 4050750 / 5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:I

Company details

EUDAMED SRN
ES-MF-000013991
EUDAMED status
Active
EUDAMED registered name
Followhealth S.L.
EUDAMED abbreviated name
vitalera
Registered address
1, Erretsundi, 20870, Elgoibar, Spain
Phone
+34628994983
PRRC contact
Unai Sánchez Luque(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 15 Sep 2031

EUDAMED certificates (1)

ENTE CERTIFICAZIONE MACCHINE SRL 1282 1 certificate

  • ECM26MDR008 Active

    Quality management system EU MDR

    Issued
    16 Sep 2026
    Expires
    15 Sep 2031

From the company website

Read 18 Sep 2026

We use IA to provide personalized patient care 24 / 7 through an app and an API integrated into your system. Ask for your demo and request information.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does Followhealth S.L. have in the registry?

The registry currently lists 2 devices for Followhealth S.L.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Followhealth S.L.'s devices?

Among its 2 most recently registered devices, Followhealth S.L. has devices listed in EUDAMED (2 devices).

What risk classes do Followhealth S.L.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Followhealth S.L.'s devices are Class I and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Followhealth S.L.?

EUDAMED lists 1 certificate for Followhealth S.L. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-09-16.

What are the newest devices from Followhealth S.L. in the registry?

The most recently registered devices listed for Followhealth S.L. include vitalera and humanITcare.

Generated automatically from registry data and not verified by a human reviewer.