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Glooko XT

by Glooko, Inc. 2 variants

Ref REF-0010

Glooko XT (REF-0010) is a Class IIa device made by Glooko, Inc., registered in EUDAMED on 18 Sep 2024 (Basic UDI-DI 0085509300REF-0010UR), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0085509300REF-0010UR Basic UDI-DI 00855093008095UDI-DIDate18 Sep 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Glooko XT Patient
Model / reference
REF-0010
Primary DI / UDI-DI
00855093008095
Basic UDI-DI
0085509300REF-0010UR
EMDN code
V92 Medical device software - not included in other classes
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
France

Manufacturer details

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

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Properties

Other properties (14, all answered No)