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Cholesterol

by Beckman Coulter Inc. 2 variants

Ref OSR6116

Cholesterol (OSR6116) is a total cholesterol lipid IVD (EU IVDR Class B; FDA Class I; FDA product code CHH, Enzymatic Esterase--Oxidase, Cholesterol) made by Beckman Coulter, Inc., registered in EUDAMED on 22 Jun 2022 (Basic UDI-DI 150995901OSR6116M2) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 15099590010140), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number150995901OSR6116M2 Basic UDI-DI 15099590010140UDI-DIDate22 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590010140 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 150995901OSR6116M2 registered 22 Jun 2022 Active
  • FDA GUDID UDI-DI 15099590010140 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15099590010140
  2. Registered EUDAMED 150995901OSR6116M2

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  • Withdrawn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
Cholesterol EUDAMED
Au GUDID
Generic name
Total cholesterol lipid IVD, kit, spectrophotometry
Model / reference
OSR6116
Primary DI / UDI-DI
15099590010140
Basic UDI-DI
150995901OSR6116M2
FDA product code
CHH
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
Total cholesterol lipid IVD, kit, spectrophotometry
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1175
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single use
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)