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C-Reactive Protein Control
EUDAMEDClass 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)
Identity
- Trade Name
- C-Reactive Protein Control EUDAMED
- Device Name
- C-Reactive Protein Control EUDAMED
- Model / Reference
- Control1:1×1.0 mL EUDAMEDMY-0003-01 EUDAMED1×1.0mL(Control 3) EUDAMEDMY-0003-03 EUDAMED1×1.0mL(Control 2) EUDAMEDMY-0003-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493097150 EUDAMED06976117453920 EUDAMED06970493097174 EUDAMED
- Basic UDI-DI
- B-06970493097150 EUDAMEDB-06976117453920 EUDAMEDB-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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06970493097150 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- 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