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Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochrom…
EUDAMEDClass IVD General (EU MDR)
Ref H7402CVModel H7402CL, H7402CV, H7403CV, H7402CC, H7404CC, H7403CC
Identity
- Trade Name
- Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Device Name
- Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- H7402CL, H7402CV, H7403CV, H7402CC, H7404CC, H7403CC EUDAMEDH7402CV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315736978 EUDAMED
- Basic UDI-DI
- B-06973315736978 EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) 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
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
Glycated Hemoglobin A1c (HbA1c) Test Kit (Quantum Dots Fluorescence Immunochrom… by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-06973315736978 | 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 ddb43189-835d-49b2-95a8-6623be619fdd 61 fields · synced Oct 6, 2026