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Logilet Respiratory Pathogen Panel
EUDAMEDClass IVD General (EU MDR)
Ref VD1011
Identity
- Trade Name
- Logilet Respiratory Pathogen Panel EUDAMED
- Device Name
- Logilet Respiratory Pathogen Panel EUDAMED
- Model / Reference
- VD1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315734882 EUDAMED
- Basic UDI-DI
- B-06973315734882 EUDAMED6973315734882AY EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMEDHungary 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Logilet Respiratory Pathogen Panel by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06973315734882 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06973315734882 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 3876d922-fc7e-4626-add1-064b56c60f2c 61 fields · synced Oct 8, 2026
- EUDAMED e2cb3204-f425-4750-bc03-a83f6dd1a16c 61 fields · synced May 17, 2026