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Urinalysis Reagent Strips (Spectroscopy)

by Shenzhen Reetoo Biotechnology Co., Ltd 2 variants

Ref /Model RT-11UT, RT-11HT, RT-11HK, RT-11A, RT-11V

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-K01003-11WB Basic UDI-DI D-K01003-11WBUDI-DIDate24 Jun 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  • Withdrawn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

Model / Reference
RT-11UT, RT-11HT, RT-11HK, RT-11A, RT-11V, /
Primary DI / UDI-DI
D-K01003-11WB
Basic UDI-DI
B-K01003-11WB
EMDN Code
W0101060205 Urine multi-constituent test strips (automated)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000011699
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Shenzhen Reetoo Biotechnology Co., Ltd

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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