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Streck

by Streck 18 variants

Ref 225480

Streck (225480) is a device classified as Class B in the EU and Class II in the US made by Streck, registered in EUDAMED on 1 May 2026 (Basic UDI-DI 08445090STKRQM), cleared under FDA 510(k) K090137 on 18 Mar 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 20844509000321), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090137

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08445090STKRQM Basic UDI-DI 20844509000321UDI-DIDate1 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20844509000321 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090137 Date18 Mar 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08445090STKRQM registered 1 May 2026 Active
  • FDA 510(k) K090137 decided 18 Mar 2009 Active
  • FDA GUDID UDI-DI 20844509000321 listed 19 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090137
  2. Listed FDA GUDID 20844509000321
  3. Registered EUDAMED 08445090STKRQM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Streck EUDAMED
STaK-Chex Plus Retics GUDID
Generic name
Full blood count IVD, control
Device name
STaK-Chex Plus Retics - 4x4.5ml Low
Model / Ref / Catalog
225480
Description
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of low level.
Primary DI / UDI-DI
20844509000321
Basic UDI-DI
08445090STKRQM
Direct marketing DI
20844509000321
510(k) Number
FDA product code
GLQ
EMDN code
W0103010503 Multilevel blood controls
GMDN term
Full blood count IVD, control
Device class
Class B EUDAMED
Class II GUDID
Regulation number
864.8625
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 4.5 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000013009
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Similar devices in this category

Other devices filed under MULTILEVEL BLOOD CONTROLS.

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Properties

  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)