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Dryspot Pneumo DR0420M

by Oxoid Limited

Ref DR0420M

Dryspot Pneumo DR0420M is a device classified as Class C in the EU and Class I in the US made by Oxoid Limited, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 5032384DrySpotPneumoQP) and listed in FDA GUDID since 4 Dec 2022 (UDI-DI 05032384086412), 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 Number5032384DrySpotPneumoQP Basic UDI-DI 05032384086412UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384086412 UDI-DI Date4 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5032384DrySpotPneumoQP registered 20 Aug 2026 Active
  • FDA GUDID UDI-DI 05032384086412 listed 4 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05032384086412
  2. Registered EUDAMED 5032384DrySpotPneumoQP

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  • Withdrawn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
Dryspot Pneumo
Generic name
Streptococcus pneumoniae culture isolate antigen IVD, kit, agglutination
Model / reference
DR0420M
Primary DI / UDI-DI
05032384086412
Basic UDI-DI
5032384DrySpotPneumoQP
FDA product code
GTZ
EMDN code
W0104080302 Streptococci grouping slide tests
GMDN term
Streptococcus pneumoniae culture isolate antigen IVD, kit, agglutination
Device class
Class C EUDAMED
Class I GUDID
Regulation number
866.3740
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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: Streptococcus pneumoniae culture isolate antigen IVD, kit, agglutination

Similar devices in this category

Other devices filed under IMMUNOLOGICAL IDENTIFICATION BY CULTURE.

Other devices from Oxoid Limited

See all devices from Oxoid Limited →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)