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13C-Spirulina Gastric Emptying Breath Test (GEBT)

by Advanced Breath Diagnostics LLC, dbaCairn Diagnostics

Ref K021

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++M763GEBTJ2 Basic UDI-DI +M763K0211UDI-DIDate13 May 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
13C-Spirulina Gastric Emptying Breath Test
Model / Reference
K021
Primary DI / UDI-DI
+M763K0211
Basic UDI-DI
++M763GEBTJ2
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000053474
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No