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VAHTS DNA Library Prep Kit for Illumina
EUDAMEDClass A (EU MDR)
Ref ND609ME-01Model ND609ME
Identity
- Trade Name
- VAHTS DNA Library Prep Kit for Illumina EUDAMED
- Device Name
- VAHTS DNA Library Prep Kit for Illumina EUDAMED
- Model / Reference
- ND609ME EUDAMEDND609ME-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315736350 EUDAMED
- Basic UDI-DI
- 6973315736343AB EUDAMED
- Direct Marketing DI
- 06973315736350 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - 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
VAHTS DNA Library Prep Kit for Illumina by Nanjing Vazyme Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6973315736343AB | 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 (1)
- EUDAMED d94948e2-9ee0-42a9-af37-158ee767c654 61 fields · synced Oct 6, 2026