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Serum Calibrator Set 62028

by Chromsystems Instruments & Chemicals GmbH

Part of a family of 33 devices: see the family page

Ref 62028

Serum Calibrator Set 62028 is a device classified as Class B in the EU and Class II in the US made by Chromsystems Instruments & Chemicals GmbH, registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 42503176200054) and listed in FDA GUDID since 22 Mar 2019 (UDI-DI 04250317519382), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number42503176200054 Basic UDI-DI 04250317519382UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250317519382 UDI-DI Date22 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503176200054 registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 04250317519382 listed 22 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250317519382
  2. Registered EUDAMED 42503176200054

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  • Withdrawn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

Trade name
3PLUS1® Multilevel Serum Calibrator Set EUDAMED
Serum Calibrator Set GUDID
Generic name
Multiple form 25-hydroxy Vitamin D IVD, calibrator
Device name
25-OH-Vitamin D3/D2 in serum/plasma
Model / Ref / Catalog
62028
Primary DI / UDI-DI
04250317519382
Basic UDI-DI
42503176200054
FDA product code
JIX
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple form 25-hydroxy Vitamin D IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter

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.

Related devices

Category: Multiple form 25-hydroxy Vitamin D IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Chromsystems Instruments & Chemicals GmbH

See all devices from Chromsystems Instruments & Chemicals GmbH →

Properties

  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)