← Back to catalogue
Serum Amyloid A Protein Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref MY-0005-03Model 1×0.5mL（Calibrator 3）
Identity
- Trade Name
- Serum Amyloid A Protein Calibrator EUDAMED
- Device Name
- Serum Amyloid A Protein Calibrator EUDAMED
- Model / Reference
- 1×0.5mL（Calibrator 3） EUDAMEDMY-0005-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970493098423 EUDAMED
- Basic UDI-DI
- B-06970493098423 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
Yes
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
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-06970493098423 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED c673c660-7758-47f0-a672-6f034b6c7bce 61 fields · synced Jun 18, 2026