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Serum Amyloid A Protein Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref MY-0005-01Model Calibrator 1 1×0.5 mlRef MY-0005-07Model 1×0.5mL（Calibrator 7）Ref MY-0005-05Model 1×0.5mL（Calibrator 5）Ref MY-0005-08Model 5×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5）Ref MY-0005-09Model 7×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5, Calibrator 6, Calibrator 7）
Identity
- Trade Name
- Serum Amyloid A Protein Calibrator EUDAMED
- Device Name
- Serum Amyloid A Protein Calibrator EUDAMED
- Model / Reference
- Calibrator 1 1×0.5 ml EUDAMEDMY-0005-01 EUDAMED1×0.5mL（Calibrator 7） EUDAMEDMY-0005-07 EUDAMED1×0.5mL（Calibrator 5） EUDAMEDMY-0005-05 EUDAMED5×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5） EUDAMEDMY-0005-08 EUDAMED7×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5, Calibrator 6, Calibrator 7） EUDAMEDMY-0005-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493098409 EUDAMED06970493098898 EUDAMED06970493098690 EUDAMED06970493098874 EUDAMED06970493098904 EUDAMED
- Basic UDI-DI
- B-06970493098409 EUDAMEDB-06970493098898 EUDAMEDB-06970493098690 EUDAMEDB-06970493098874 EUDAMEDB-06970493098904 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
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Serum Amyloid A 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-06970493098409 | 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 e12623d6-44ee-452c-85f0-703540c78d97 61 fields · synced Jul 9, 2026
- EUDAMED c1c98769-e0bf-4f51-9e99-4f4e7579e277 61 fields · synced Jun 18, 2026
- EUDAMED 1b1860ef-247a-45e8-b74e-f5739b70dc1e 61 fields · synced Jun 20, 2026
- EUDAMED c4e1e161-d39e-444a-a268-3ea958c4217d 61 fields · synced Jul 9, 2026
- EUDAMED e2b8d35a-dfe9-4c4d-a668-a5b3a5ed6727 61 fields · synced Jul 9, 2026