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Sinocare

by Changsha Sinocare Inc. 10 variants

Ref 12200242Model UA101

Active European Union

CE IVDR

Valid until

29 Jul 2031

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 NumberV76 060250 0034 Date30 Jul 2026IssuedStatusActive expires 29 Jul 2031

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  • Withdrawn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
Uric Acid Test Strip
Model / Reference
UA101, 12200242
Primary DI / UDI-DI
06934175049509
Basic UDI-DI
6934175001B0226P6
Direct Marketing DI
06934175049509
EMDN Code
W0101060199 Blood test strips (cc) - rapid tests and "point of care" - other
Device Class
Class C
EU market of registration
Germany

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

  • Microbial Substances
  • Reagent
  • Self Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No