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AcuteckTM Blood Glucose Control Solution

by Assure Tech. (Hangzhou) Co., Ltd.

Ref C902095

Active European Union

CE IVDR

Valid until

16 Mar 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69528048GHP-101ProSKZ9 Basic UDI-DI 06952804819897UDI-DIDate28 Jul 2026RegisteredStatusActive

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  • Withdrawn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 Monitoring System
Model / Reference
C902095
Primary DI / UDI-DI
06952804819897
Basic UDI-DI
69528048GHP-101ProSKZ9
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class C
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002170
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Assure Tech. (Hangzhou) Co., Ltd.

See all devices from Assure Tech. (Hangzhou) Co., Ltd. →

Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Surgical Instrument

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No