Skip to content

Creatinine Assay Kit (Sarcosine Oxidase Method)

by Da Te Bioengineering Technology Co., LTD. 8 variants

Ref DTSH030201Model R1: 60 mL×4; R2: 20 mL×4

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975225462824 Basic UDI-DI 06975225462824UDI-DIDate2 Mar 2023RegisteredStatusActive

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  • Withdrawn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
Creatinine Assay Kit (Sarcosine Oxidase Method)
Model / Reference
R1: 60 mL×4, R2: 20 mL×4, DTSH030201
Primary DI / UDI-DI
06975225462824
Basic UDI-DI
B-06975225462824
EMDN Code
W01010207 Creatinine
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000028832
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Da Te Bioengineering Technology Co., LTD.

See all devices from Da Te Bioengineering Technology Co., LTD. →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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