Skip to content

Streck

by Streck 4 variants

Ref 213362Model 213559

Streck (213362) is a device classified as Class A in the EU and Class II in the US made by Streck, registered in EUDAMED on 1 May 2026 (Basic UDI-DI 08445090BCTTZ), cleared under FDA 510(k) K080552 on 31 Jul 2008 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 20844509000826), active as of 22 Oct 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080552

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 Number08445090BCTTZ Basic UDI-DI 20844509000826UDI-DIDate1 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20844509000826 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK080552 Date31 Jul 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08445090BCTTZ registered 1 May 2026 Active
  • FDA 510(k) K080552 decided 31 Jul 2008 Active
  • FDA GUDID UDI-DI 20844509000826 listed 16 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1684-2017 FDA Class II initiated 23 Feb 2017

    Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.

Timeline

4 dated events

  1. Cleared FDA 510(k) K080552
  2. Listed FDA GUDID 20844509000826
  3. Recall initiated FDA recalls Z-1684-2017
  4. Registered EUDAMED 08445090BCTTZ

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  • Withdrawn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
Cyto-Chex BCT GUDID
Generic name
Evacuated blood collection tube IVD, K3EDTA
Device name
Cyto-Chex BCT 6-tube pack (2.0 ml) glass
Model / Ref / Catalog
213559, 213362
Description
A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 5 ml vials.
Primary DI / UDI-DI
20844509000826
Basic UDI-DI
08445090BCTTZ
Direct marketing DI
20844509000826
510(k) Number
FDA product code
GIM
EMDN code
W050101010201 Blood collection, tubes with additives or serum separator
GMDN term
Evacuated blood collection tube IVD, K3EDTA
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1675
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5.0 Milliliter

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.

Manufacturer details

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

Similar devices in this category

Other devices filed under BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR.

Other devices from Streck

See all devices from Streck →

Properties

  • Supplied sterile
  • Single use
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)