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Capillarys 3 Dbs 1244

by Sebia

Ref 1244

Capillarys 3 Dbs 1244 is a device classified as Class A in the EU and Class II in the US made by Sebia, cleared under FDA 510(k) K232027 on 4 Apr 2024, registered in EUDAMED on 27 Jun 2022 (Basic UDI-DI 3607361244BUC3) and listed in FDA GUDID since 30 Apr 2024 (UDI-DI 03607360012444), active as of 12 Nov 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232027

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03607360012444 UDI-DI Date30 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232027 Date4 Apr 2024DecidedStatusActive
European UnionCE/IVDR EUDAMED Number3607361244BUC3 Basic UDI-DI 03607360012444UDI-DIDate27 Jun 2022RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K232027 decided 4 Apr 2024 Active
  • EUDAMED Basic UDI-DI 3607361244BUC3 registered 27 Jun 2022 Active
  • FDA GUDID UDI-DI 03607360012444 listed 30 Apr 2024 Listed

Timeline

3 dated events

  1. Registered EUDAMED 3607361244BUC3
  2. Cleared FDA 510(k) K232027
  3. Listed FDA GUDID 03607360012444

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Capillarys 3 Dbs
Generic name
Electrophoresis analyser IVD
Model / Ref / Catalog
1244
Primary DI / UDI-DI
03607360012444
Basic UDI-DI
3607361244BUC3
510(k) Number
FDA product code
GKA
EMDN code
W020105010202 Capillary electrophoresis systems
GMDN term
Electrophoresis analyser IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.7415
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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

Category: Electrophoresis analyser IVD

Cleared under the same submission (K232027)

Similar devices in this category

Other devices filed under ELECTROPHORESIS INSTRUMENTS.

Other devices from Sebia

See all devices from Sebia →

Properties

  • IVD kit
  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (21, all answered No)