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C-Reactive Protein Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref PO-0021-01Model Calibrator1:0.5mL×1Ref MY-0002-05Model 1×0.5mL（Calibrator 5）Ref MY-0002-07Model 6×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5, Calibrator 6）Ref MY-0002-03Model 1×0.5mL（Calibrator 3）Ref MY-0002-02Model 1×0.5mL（Calibrator 2）
Identity
- Trade Name
- C-Reactive Protein Calibrator EUDAMED
- Device Name
- C-Reactive Protein Calibrator EUDAMED
- Model / Reference
- Calibrator1:0.5mL×1 EUDAMEDPO-0021-01 EUDAMED1×0.5mL（Calibrator 5） EUDAMEDMY-0002-05 EUDAMED6×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5, Calibrator 6） EUDAMEDMY-0002-07 EUDAMED1×0.5mL（Calibrator 3） EUDAMEDMY-0002-03 EUDAMED1×0.5mL（Calibrator 2） EUDAMEDMY-0002-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493097167 EUDAMED06970493098300 EUDAMED06970493098324 EUDAMED06970493098287 EUDAMED06970493098270 EUDAMED
- Basic UDI-DI
- B-06970493097167 EUDAMEDB-06970493098300 EUDAMEDB-06970493098324 EUDAMEDB-06970493098287 EUDAMEDB-06970493098270 EUDAMED
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS 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
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
C-Reactive Protein Calibrator 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-06970493097167 | 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 (5)
- EUDAMED 43559218-bd9c-49bc-be8a-3047fbe96723 61 fields · synced Oct 6, 2026
- EUDAMED 51d4f475-36a3-4a15-b02d-293eb66e6bc6 61 fields · synced Jun 20, 2026
- EUDAMED 2fa0a645-bc7a-43fe-bcd0-e4d7ffc4516c 61 fields · synced Jul 9, 2026
- EUDAMED 2bddcdff-2e5d-4ce8-ae35-52e073057990 61 fields · synced Jul 18, 2026
- EUDAMED 853d9c55-9a1a-436b-885c-6bd6f2787d70 61 fields · synced Jul 27, 2026