Skip to content

Glooko Mobile Application

by Glooko, Inc.

Ref REF-0002

Glooko Mobile Application (REF-0002) is a device classified as Class IIa in the EU and Class I in the US made by Glooko, Inc., registered in EUDAMED on 4 Sep 2024 (Basic UDI-DI 0085509300MobileRef0023N) and listed in FDA GUDID since 16 Feb 2021 (UDI-DI 00855093008033), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0085509300MobileRef0023N Basic UDI-DI 00855093008033UDI-DIDate4 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00855093008033 UDI-DI Date16 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0085509300MobileRef0023N registered 4 Sep 2024 Active
  • FDA GUDID UDI-DI 00855093008033 listed 16 Feb 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00855093008033
  2. Registered EUDAMED 0085509300MobileRef0023N

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Clinical decision management support software
Model / reference
REF-0002 EUDAMED
5.xx GUDID
Primary DI / UDI-DI
00855093008033
Basic UDI-DI
0085509300MobileRef0023N
FDA product code
PHV
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Clinical decision management support software
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
862.2120
Special device type
Software
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REF-0002
GUDID
5.xx
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000023483
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Glooko, Inc.

See all devices from Glooko, Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)