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Logilet Logicore System
EUDAMEDClass A (EU MDR)
Ref Logicore-a; Logicore-oModel Logicore
Identity
- Trade Name
- Logilet Logicore System EUDAMED
- Device Name
- Logilet Logicore System EUDAMED
- Model / Reference
- Logicore EUDAMEDLogicore-a; Logicore-o EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315734936 EUDAMED
- Basic UDI-DI
- 6973315734769B3 EUDAMED
- Direct Marketing DI
- 06973315734936 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
Logilet Logicore System by Nanjing Vazyme Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6973315734769B3 | 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 bb4c4923-6b67-4ed5-b0df-9a0addeddb96 61 fields · synced Jul 12, 2026
- EUDAMED bb4c4923-6b67-4ed5-b0df-9a0addeddb96-1 61 fields · synced Jun 9, 2026