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HC WBC Diff Control

by R&D Systems, Inc. 4 variants

Ref HWBCD02

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00815762026522 Basic UDI-DI 00815762026522UDI-DIDate26 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device name
Hewd
Model / reference
HWBCD02
Primary DI / UDI-DI
00815762026522
Basic UDI-DI
B-00815762026522
EMDN code
W0103010503 Multilevel blood controls
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000024485
Authorised representative
BIO-TECHNE SAS FR-AR-000011963

Other devices from R&D Systems, Inc.

See all devices from R&D Systems, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Near-patient testing

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains substances of microbial origin: No
  • Reagent: No
  • IVD kit: No
  • Self-testing: No
  • Professional testing: No
  • Companion diagnostics: No
  • IVD instrument: No