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Para 12 Extend 218994

by Streck

Part of a family of 8 devices: see the family page

Ref 218994Model 218750

Para 12 Extend 218994 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 0844509012EXT5Y), cleared under FDA 510(k) K823498 on 28 Dec 1982 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 30844509000632), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K823498

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0844509012EXT5Y Basic UDI-DI 30844509000632UDI-DIDate1 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30844509000632 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK823498 Date28 Dec 1982DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0844509012EXT5Y registered 1 May 2026 Active
  • FDA 510(k) K823498 decided 28 Dec 1982 Active
  • FDA GUDID UDI-DI 30844509000632 listed 14 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K823498
  2. Listed FDA GUDID 30844509000632
  3. Registered EUDAMED 0844509012EXT5Y

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  • Withdrawn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
Para 12 Extend GUDID
Generic name
Full blood count IVD, control
Device name
Para 12 EXT - 18 x 2.5 mL (6 Low, 6 Normal, 6 High)
Model / Ref / Catalog
218994, 218750
Description
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of high level.
Primary DI / UDI-DI
30844509000632
Basic UDI-DI
0844509012EXT5Y
Direct marketing DI
30844509000632
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 — 2.5 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.

Related devices

Category: Full blood count IVD, control

Cleared under the same submission (K823498)

and 2 more cleared under K823498

Similar devices in this category

Other devices filed under MULTILEVEL BLOOD CONTROLS.

Other devices from Streck

See all devices from Streck →

Properties

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