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Sinocare

by Changsha Sinocare Inc. 19 variants

Ref REF 8C001, REF 8C002Model Level 1, Level 2

Active European Union

CE IVDR

Valid until

28 Apr 2029

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6934175001C0501PG Basic UDI-DI 06934175009930UDI-DIDate25 Mar 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Hemoglobin Control Solution
Model / Reference
Level 1, Level 2, REF 8C001, REF 8C002
Primary DI / UDI-DI
06934175009930
Basic UDI-DI
6934175001C0501PG
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class B

Manufacturer details

EUDAMED SRN
CN-MF-000012244
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Changsha Sinocare Inc.

See all devices from Changsha Sinocare Inc. →

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No