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EZER NAAT SARS-CoV-2 real-time RT-PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref N211101
Identity
- Trade Name
- EZER NAAT SARS-CoV-2 real-time RT-PCR Kit EUDAMED
- Model / Reference
- N211101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698600743 EUDAMED
- Basic UDI-DI
- B-16972698600743 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
EZER NAAT SARS-CoV-2 real-time RT-PCR Kit by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-16972698600743 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9f181f66-2d03-4abc-8101-0ed359a9082a 61 fields · synced Oct 7, 2026