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Para 12 Plus 218913

by Streck

Ref 218913

Para 12 Plus 218913 is a device classified as Class B in the EU and Class II in the US made by Streck, registered in EUDAMED on 28 May 2024 (Basic UDI-DI 0844509012+MH), cleared under FDA 510(k) K901875 on 30 May 1990 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 00844509000235), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K901875

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0844509012+MH Basic UDI-DI 00844509000235UDI-DIDate28 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00844509000235 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK901875 Date30 May 1990DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0844509012+MH registered 28 May 2024 Active
  • FDA 510(k) K901875 decided 30 May 1990 Active
  • FDA GUDID UDI-DI 00844509000235 listed 14 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K901875
  2. Listed FDA GUDID 00844509000235
  3. Registered EUDAMED 0844509012+MH

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  • Withdrawn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
Para 12 Plus
Generic name
Full blood count IVD, control
Model / Ref / Catalog
218913
Primary DI / UDI-DI
00844509000235
Basic UDI-DI
0844509012+MH
Direct marketing DI
00844509000235
510(k) Number
FDA product code
JCN
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 — 3.0 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.

Related devices

Category: Full blood count IVD, control

Cleared under the same submission (K901875)

Similar devices in this category

Other devices filed under MULTILEVEL BLOOD CONTROLS.

Other devices from Streck

See all devices from Streck →

Properties

  • Contains human tissues or cells
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)