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C-Reactive Protein Reagent (Immunonephelometric Method)

by Shenzhen Dymind Biotechnology Co., Ltd.

Ref MY-0001-09Model R ：1×13mL （75mm×45mm×105mm）, R ：2×75mL （78mm×78mm×145mm）

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number6970493090506007P5 Basic UDI-DI 06976117454187UDI-DIDate15 Jun 2026RegisteredStatusActive
European UnionCE/IVDR Number6970493090506007P5 Basic UDI-DI 06976117454187UDI-DIDate15 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Model / Reference
R ：1×13mL （75mm×45mm×105mm）, MY-0001-09, R ：2×75mL （78mm×78mm×145mm）
Primary DI / UDI-DI
06976117454187
Basic UDI-DI
6970493090506007P5, B-06976117454187
Direct Marketing DI
06976117454187
EMDN Code
W01021109 C-reactive protein
Device Class
Class C
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024842
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Shenzhen Dymind Biotechnology Co., Ltd.

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No