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National labs RS24003

by Rda Spot, Uab

Ref RS24003

National labs RS24003 is a device classified as Class A in the EU and Class II in the US made by Rda Spot, Uab, registered in EUDAMED on 24 May 2026 (Basic UDI-DI 477905472RS24003K4) and listed in FDA GUDID since 6 Sep 2024 (UDI-DI 04779054720726), active as of 23 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number477905472RS24003K4 Basic UDI-DI 04779054720726UDI-DIDate24 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04779054720726 UDI-DI Date6 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 477905472RS24003K4 registered 24 May 2026 Active
  • FDA GUDID UDI-DI 04779054720726 listed 6 Sep 2024 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 04779054720726
  2. Registered EUDAMED 477905472RS24003K4

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  • Withdrawn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
IVD Sample Collection Kit EUDAMED
National labs GUDID
Generic name
Capillary blood collection kit IVD
Model / reference
RS24003
Primary DI / UDI-DI
04779054720726
Basic UDI-DI
477905472RS24003K4
Direct marketing DI
04779054720726
FDA product code
PQD
EMDN code
W0501010199, W0501010299
GMDN term
Capillary blood collection kit IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1675
EU registration type
Standard device
EU market of registration
Lithuania
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

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

Similar devices in this category

Other devices filed under VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER.

Other devices from Rda Spot, Uab

See all devices from Rda Spot, Uab →

Properties

  • Single use
  • IVD kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)