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C-Reactive Protein Reagent (Immunonephelometric Method)

EUDAMED

Class IVD General (EU MDR)

Ref MY-0001-01Model 13 mL R：1×13 mL （75mm×45mm×105mm）Ref MY-0001-02Model R 1×25mL （75mm×45mm×105mm）Ref MY-0001-03Model R 1×45mL （75mm×45mm×105mm）Ref MY-0001-06Model R ：2×13mL （75mm×45mm×105mm）

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
C-Reactive Protein Reagent (Immunonephelometric Method) EUDAMED
Device Name
C-Reactive Protein Reagent (Immunonephelometric Method) EUDAMED
Model / Reference
13 mL R：1×13 mL （75mm×45mm×105mm） EUDAMED
MY-0001-01 EUDAMED
R 1×25mL （75mm×45mm×105mm） EUDAMED
MY-0001-02 EUDAMED
R 1×45mL （75mm×45mm×105mm） EUDAMED
MY-0001-03 EUDAMED
R ：2×13mL （75mm×45mm×105mm） EUDAMED
MY-0001-06 EUDAMED

Identifiers

Primary DI / UDI-DI
06976117454101 EUDAMED
06976117454118 EUDAMED
06976117454125 EUDAMED
06976117454156 EUDAMED
Basic UDI-DI
B-06976117454101 EUDAMED
B-06976117454118 EUDAMED
B-06976117454125 EUDAMED
B-06976117454156 EUDAMED
EMDN Code
W01021109 C-REACTIVE PROTEIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMEDEUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

C-Reactive Protein Reagent (Immunonephelometric Method) by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen Dymind Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000024842
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (4)

  • EUDAMED 8b6bfec1-44da-4480-a053-c144265f1873 61 fields · synced Oct 6, 2026
  • EUDAMED d2ae62fc-3b1e-41c1-86df-d4f0aa204454 61 fields · synced Jul 9, 2026
  • EUDAMED fdb2e0ea-a7e8-44e7-928d-c105f762688d 61 fields · synced Jul 10, 2026
  • EUDAMED 53101b5f-987a-4a02-9368-44a87b599471 61 fields · synced Jul 31, 2026