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IF Sprinter YG 0032-0101

by EUROIMMUN Medizinische Labordiagnostika AG

Ref YG 0032-0101Model YG 0032

IF Sprinter YG 0032-0101 is a device classified as Class A in the EU and Class I in the US made by EUROIMMUN Medizinische Labordiagnostika AG, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 4049016YG0032G9) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04049016100577), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4049016YG0032G9 Basic UDI-DI 04049016100577UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016100577 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049016YG0032G9 registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 04049016100577 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049016100577
  2. Registered EUDAMED 4049016YG0032G9

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  • Withdrawn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
IF Sprinter
Generic name
Multichannel immunoassay analyser IVD
Model / reference
YG 0032-0101, YG 0032
Primary DI / UDI-DI
04049016100577
Basic UDI-DI
4049016YG0032G9
FDA product code
JQW, JJE
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Multichannel immunoassay analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2750, 862.2160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Related devices

Category: Multichannel immunoassay analyser IVD

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h).

Other devices from EUROIMMUN Medizinische Labordiagnostika AG

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Properties

  • Professional testing
  • IVD instrument
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)