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Glooko Transmitter

by Glooko, Inc.

Ref REF-0003

Glooko Transmitter (REF-0003) is a Class I device made by Glooko, Inc., registered in EUDAMED on 4 Sep 2024 (Basic UDI-DI 0085509300TransRef003SQ), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0085509300TransRef003SQ Basic UDI-DI 00855093008057UDI-DIDate4 Sep 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
REF-0003
Primary DI / UDI-DI
00855093008057
Basic UDI-DI
0085509300TransRef003SQ
Direct marketing DI
00855093008057
EMDN code
V92 Medical device software - not included in other classes
Device class
Class I
EU registration type
Standard device
EU market of registration
Sweden

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)