Skip to content

Aripiprazole (ARI) Test Kit

by Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.

Ref 1test/kit

Active European Union

CE IVDD

Valid until

Not listed

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06980370960026 Basic UDI-DI 06980370960026UDI-DIDate13 Aug 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  • Withdrawn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
Aripiprazole (ARI) Test Kit
Model / Reference
1test/kit
Primary DI / UDI-DI
06980370960026
Basic UDI-DI
B-06980370960026
EMDN Code
W01020899 Therapeutic drug monitoring - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057448
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.

See all devices from Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd. →

Properties

  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No