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Quality Control Kit for Logilet Respiratory Pathogen Panel
EUDAMEDClass IVD General (EU MDR)
Ref QC1011
Identity
- Trade Name
- Quality Control Kit for Logilet Respiratory Pathogen Panel EUDAMED
- Device Name
- Quality Control Kit for Logilet Respiratory Pathogen Panel EUDAMED
- Model / Reference
- QC1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315734875 EUDAMED
- Basic UDI-DI
- B-06973315734875 EUDAMED6973315734875B3 EUDAMED
- EMDN Code
- W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Quality Control Kit for 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-06973315734875 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06973315734875 | 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 f63713f6-eaf8-423a-a74f-f484bf562351 61 fields · synced Oct 6, 2026
- EUDAMED 306b2078-0ce1-4d70-be03-863c93fcfab5 61 fields · synced May 19, 2026