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eBcarryon eB-A

by Visgeneer, Inc.

Ref 1320500Model eB-A

eBcarryon eB-A is a glucose monitoring system IVD (EU IVDD Annex II List B; FDA Class II; FDA product code CGA, Glucose Oxidase, Glucose) made by Visgeneer, Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-04712558769082), cleared under FDA 510(k) K091765 on 19 Jan 2010 and listed in FDA GUDID since 17 Apr 2026 (UDI-DI 04712558769082), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091765

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-04712558769082 Basic UDI-DI 04712558769082UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04712558769082 UDI-DI Date17 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK091765 Date19 Jan 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04712558769082 registered 28 Oct 2026 Active
  • FDA 510(k) K091765 decided 19 Jan 2010 Active
  • FDA GUDID UDI-DI 04712558769082 listed 17 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091765
  2. Listed FDA GUDID 04712558769082
  3. Registered EUDAMED B-04712558769082

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
eBcarryon
Generic name
Glucose monitoring system IVD, home-use
Device name
eBcarryon Blood Glucose Monitoring System
Model / reference
eB-A, 1320500
Primary DI / UDI-DI
04712558769082
Basic UDI-DI
B-04712558769082
510(k) Number
FDA product code
CGA
EMDN code
W02010199 Chemistry instruments - other
GMDN term
Glucose monitoring system IVD, home-use
Device class
Class IVD Annex II List B EUDAMED
Class II GUDID
Regulation number
862.1345
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD Annex II List B
GUDID
Class II

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

Related devices

Cleared under the same submission (K091765)

Similar devices in this category

Other devices filed under CHEMISTRY INSTRUMENTS - OTHER.

Other devices from Visgeneer, Inc.

See all devices from Visgeneer, Inc. →

Properties

  • Contains substances of microbial origin
  • IVD kit
  • Self-testing
  • Near-patient testing
  • Professional testing
  • IVD instrument
  • Over-the-counter
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (15, all answered No)