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Augmedit B.V.

Active in EUDAMED

Netherlandsfrom SRN EUDAMED FDA SRN NL-MF-000045948

Devices
5
Registrations
EUDAMEDFDA
FDA recalls
0

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
United States
FDA establishment

Catalogue5

Newest first, rows 1-5 of 5

  • Lumi Segment Ref 01

    Class IIb
    Active CE MDR EUDAMED IIb

  • Lumi Referenced Ref 01

    Class IIb
    Active CE MDR EUDAMED IIb

  • LumiNE US; Lumi Ref K240094

    Class II
    Active 510(k) 510(k) II

  • Lumi Calculation Functions Ref 01

    Class I
    Active CE MDR EUDAMED I

  • Lumi Prepare Ref 01

    Class IIb
    Active CE MDR EUDAMED IIb

Company details

EUDAMED SRN
NL-MF-000045948
EU VAT number
NL 8593.90.603.B01
EUDAMED status
Active
EUDAMED registered name
Augmedit B.V.
Registered address
15, Galerij, 1411 LH, Naarden, Netherlands
Phone
+31 617 1010 94
PRRC contact
Bryan Bhoelai(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 6 Oct 2030

EUDAMED certificates (1)

Notified body 3022 1 certificate

  • SCAR-8.2.1.4 Amended

    Quality management system EU MDR

    Issued
    26 May 2026
    Expires
    6 Oct 2030
    Reason
    Other

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • AugmedIT B.V. US

Frequently asked questions

How many devices does Augmedit B.V. have in the registry?

The registry currently lists 5 devices for Augmedit B.V.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Augmedit B.V.'s devices?

Among its 5 most recently registered devices, Augmedit B.V. has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Augmedit B.V.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Augmedit B.V.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Augmedit B.V.?

EUDAMED lists 1 certificate for Augmedit B.V. (quality management system) under MDR. The most recent was issued on 2026-05-26.

What are the newest devices from Augmedit B.V. in the registry?

The most recently registered devices listed for Augmedit B.V. include Lumi Segment, Lumi Referenced, LumiNE US; Lumi and Lumi Calculation Functions.

Which FDA establishments are linked to Augmedit B.V.?

1 FDA establishment is linked to Augmedit B.V. in the registry; they are listed on the company page.

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