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Hematocrit Control High

by Edan Instruments, Inc.

Ref Hematocrit Control High

Hematocrit Control High is a device classified as IVD General (EU), Class II (US) made by Edan Instruments, Inc., registered in EUDAMED on 29 Dec 2025 (Basic UDI-DI B-06944413802018), cleared under FDA 510(k) K151978 on 15 Jul 2016 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06944413802018), active as of 22 Oct 2026.

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

CE IVDD 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, self-declared

Class I: no certifier involved

510(k) K151978

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/IVDD EUDAMED NumberB-06944413802018 Basic UDI-DI 06944413802018UDI-DIDate29 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413802018 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK151978 Date15 Jul 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06944413802018 registered 29 Dec 2025 Active
  • FDA 510(k) K151978 decided 15 Jul 2016 Active
  • FDA GUDID UDI-DI 06944413802018 listed 1 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K151978
  2. Listed FDA GUDID 06944413802018
  3. Registered EUDAMED B-06944413802018

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Controls EUDAMED
Hematocrit Control GUDID
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Model / reference
Hematocrit Control High EUDAMED
High GUDID
Primary DI / UDI-DI
06944413802018
Basic UDI-DI
B-06944413802018
510(k) Number
FDA product code
GLK
EMDN code
W0101050204 Electrolyte controls
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.8625
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Hematocrit Control High
GUDID
High
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Cleared under the same submission (K151978)

and 1 more cleared under K151978

Similar devices in this category

Other devices filed under ELECTROLYTE CONTROLS.

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Single use
  • Reagent
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)