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Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref A3402CVModel A3402CL, A3402CV, A3403CC, A3403CV, A3404CC, A3402CC
Identity
- Trade Name
- Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Device Name
- Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- A3402CL, A3402CV, A3403CC, A3403CV, A3404CC, A3402CC EUDAMEDA3402CV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315736954 EUDAMED
- Basic UDI-DI
- B-06973315736954 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography) by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDD — listed…
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-06973315736954 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 4c70a026-29e9-45d7-a22e-467e87801fef 61 fields · synced Oct 8, 2026