← Back to catalogue
VAHTS DNA Library Prep Kit for MGI
EUDAMEDClass A (EU MDR)
Ref NDM609ME-02Ref NDM609ME-01
Identity
- Trade Name
- VAHTS DNA Library Prep Kit for MGI EUDAMED
- Device Name
- VAHTS DNA Library Prep Kit for MGI EUDAMED
- Model / Reference
- NDM609ME-02 EUDAMEDNDM609ME-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315738996 EUDAMED06973315739009 EUDAMED
- Basic UDI-DI
- 6973315738996CC 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
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
New Device
No
EUDAMED
VAHTS DNA Library Prep Kit for MGI 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 | 6973315738996CC | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
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 a7b2f69f-7898-4f46-8a08-6acd2c9a2eb7 61 fields · synced Oct 6, 2026
- EUDAMED 4d904b28-10df-411b-ad58-f79f445b24a4 61 fields · synced May 18, 2026