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SARS-CoV-2 Detection Kit (Direct Fluorescence PCR）
EUDAMEDClass IVD General (EU MDR)
Ref ACOV01-AHG48E; ACOV01-AHG96E
Identity
- Device Name
- SARS-CoV-2 Detection Kit (Direct Fluorescence PCR） EUDAMED
- Model / Reference
- ACOV01-AHG48E; ACOV01-AHG96E EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-81649002ACOV01DTMB EUDAMED
- Basic UDI-DI
- B-81649002ACOV01DTMB EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 Detection Kit (Direct Fluorescence PCR） by Healgen Scientific Limited Liability Company — 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-81649002ACOV01DTMB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Healgen Scientific Limited Liability Company
- EUDAMED SRN
- US-MF-000018839
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED b1fbbbcc-292f-4028-85d3-8d1167be64f0-1 61 fields · synced Oct 6, 2026
- EUDAMED b1fbbbcc-292f-4028-85d3-8d1167be64f0-2 61 fields · synced Jul 21, 2026