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Blood Glucose Control Solution Level 1

by Changsha Sinocare Inc.

Ref 1A003Model Level 1

Active European Union

CE IVDR

Valid until

5 Dec 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6934175001C0102NW Basic UDI-DI 06934175030446UDI-DIDate12 Nov 2025RegisteredStatusActive

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  • Withdrawn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
Blood Glucose Control Solution
Model / Reference
Level 1, 1A003
Primary DI / UDI-DI
06934175030446
Basic UDI-DI
6934175001C0102NW
Direct Marketing DI
06934175030446
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class C
EU market of registration
Italy

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
  • Self Testing
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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