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VAMNE MaqUltra Circulating Cell-free DNA lsolation Mini Kit (Prepackaged)
EUDAMEDClass A (EU MDR)
Ref N904-C1ME
Identity
- Trade Name
- VAMNE MaqUltra Circulating Cell-free DNA lsolation Mini Kit (Prepackaged) EUDAMEDVAMNE MaqUltra Circulating Cell-free DNA lsolation Mini Kit (Prepackaged)VAMNE MagUltra Circulating Cell-free DNA Isolation Mini Kit (Prepackaged) EUDAMED
- Device Name
- VAMNE MaqUltra Circulating Cell-free DNA lsolation Mini Kit (Prepackaged) EUDAMEDVAMNE MagUltra Circulating Cell-free DNA Isolation Mini Kit (Prepackaged) EUDAMED
- Model / Reference
- N904-C1ME EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315736367 EUDAMED
- Basic UDI-DI
- 6973315736367AR EUDAMED
- Direct Marketing DI
- 06973315736367 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
VAMNE MaqUltra Circulating Cell-free DNA lsolation Mini Kit (Prepackaged) by Nanjing Vazyme Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6973315736367AR | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 27f8bb62-d9e8-47a5-8f20-691e2a73509f 61 fields · synced Jun 18, 2026
- EUDAMED fd07bfca-6bcf-4523-9ced-970a1ae32bce 61 fields · synced Jun 18, 2026