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C-Reactive Protein Control

EUDAMED

Class IVD General (EU MDR)

Ref MY-0003-01Model Control1:1×1.0 mLRef MY-0003-03Model 1×1.0mL(Control 3)Ref MY-0003-02Model 1×1.0mL(Control 2)

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
C-Reactive Protein Control EUDAMED
Device Name
C-Reactive Protein Control EUDAMED
Model / Reference
Control1:1×1.0 mL EUDAMED
MY-0003-01 EUDAMED
1×1.0mL(Control 3) EUDAMED
MY-0003-03 EUDAMED
1×1.0mL(Control 2) EUDAMED
MY-0003-02 EUDAMED

Identifiers

Primary DI / UDI-DI
06970493097150 EUDAMED
06976117453920 EUDAMED
06970493097174 EUDAMED
Basic UDI-DI
B-06970493097150 EUDAMED
B-06976117453920 EUDAMED
B-06970493097174 EUDAMED
EMDN Code
W0102152003 SPECIFIC PROTEIN CONTROLS 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 Control by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

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

Sources (3)

  • EUDAMED 3c32cdc1-bbed-4e7e-9376-aaf1fffa95b9 61 fields · synced Oct 6, 2026
  • EUDAMED 733ad4c0-eab3-4fe0-bcb7-c5f9289aad45 61 fields · synced Jul 8, 2026
  • EUDAMED 53ff56ca-4e7e-452c-adcc-ab57f9b10c61 61 fields · synced Sep 18, 2026