← Back to catalogue
SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)
EUDAMEDClass IVD General (EU MDR)
Ref 528006Model 48 Rxns/kit Ref 528007Model 96 Rxns/kit
Identity
- Device Name
- SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) EUDAMED
- Model / Reference
- 48 Rxns/kit EUDAMED528006 EUDAMED96 Rxns/kit EUDAMED528007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341688134 EUDAMED06970341688141 EUDAMED
- Basic UDI-DI
- B-06970341688134 EUDAMEDB-06970341688141 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER 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
SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed…
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-06970341688134 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 6da67b71-fa00-4e82-a243-525a271d36ed 61 fields · synced Jul 11, 2026
- EUDAMED ad010502-e2eb-4b71-9d11-5be3f6673d48 61 fields · synced May 17, 2026