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Csf Control - Level 3 (Csf Control 3)

by Randox Laboratories Limited

Ref CF1501

Csf Control - Level 3 (Csf Control 3) (CF1501) is a device classified as Class B in the EU and Class I in the US made by Randox Laboratories Limited, registered in EUDAMED on 3 Feb 2026 (Basic UDI-DI 50552732BCSFCON038D6) and listed in FDA GUDID since 4 Oct 2022 (UDI-DI 05055273201123), 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 Number50552732BCSFCON038D6 Basic UDI-DI 05055273201123UDI-DIDate3 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055273201123 UDI-DI Date4 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 50552732BCSFCON038D6 registered 3 Feb 2026 Active
  • FDA GUDID UDI-DI 05055273201123 listed 4 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055273201123
  2. Registered EUDAMED 50552732BCSFCON038D6

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  • Withdrawn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, control
Model / reference
CF1501
Primary DI / UDI-DI
05055273201123
Basic UDI-DI
50552732BCSFCON038D6
FDA product code
JJY
EMDN code
W0101050208 Csf controls
GMDN term
Multiple-type clinical chemistry analyte profile IVD, control
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Northern 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
XI-MF-000028410

Similar devices in this category

Other devices filed under SPECIFIC CONTROLS (CLINICAL CHEMISTRY).

Other devices from Randox Laboratories Limited

See all devices from Randox Laboratories Limited →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)