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Elical 2

by VitalScientific

Ref CALI-0550

Elical 2 (CALI-0550) is a device classified as Class B in the EU and Class II in the US made by Vitalscientific, registered in EUDAMED on 1 Oct 2025 (Basic UDI-DI 37017008CALI043X) and listed in FDA GUDID since 4 Mar 2026 (UDI-DI 03701700817802), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03701700817802 UDI-DI Date4 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number37017008CALI043X Basic UDI-DI 03701700817802UDI-DIDate1 Oct 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 37017008CALI043X registered 1 Oct 2025 Active
  • FDA GUDID UDI-DI 03701700817802 listed 4 Mar 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 37017008CALI043X
  2. Listed FDA GUDID 03701700817802

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Model / reference
CALI-0550
Primary DI / UDI-DI
03701700817802
Basic UDI-DI
37017008CALI043X
FDA product code
JIX
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1150
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 B
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
FR-MF-000004722

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Vitalscientific

See all devices from Vitalscientific →

Properties

  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)