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Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref C1402CVModel C1402CL, C1403CV, C1402CV, C1402CC, C1404CC, C1403CC
Identity
- Trade Name
- Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Device Name
- Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- C1402CL, C1403CV, C1402CV, C1402CC, C1404CC, C1403CC EUDAMEDC1402CV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315736879 EUDAMED
- Basic UDI-DI
- B-06973315736879 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN 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
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography) 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-06973315736879 | 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 e05629d8-cbb7-4c87-9e7a-6a08b3637778 61 fields · synced Oct 6, 2026