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COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) Specimens: Nasopharynge…
EUDAMEDClass IVD General (EU MDR)
Ref COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) Specimens: Nasopharyngeal swab/ Nasal swab
Identity
- Device Name
- COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) Specimens: Nasopharyngeal swab/ Nasal swab EUDAMED
- Model / Reference
- COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) Specimens: Nasopharyngeal swab/ Nasal swab EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975445472016 EUDAMED
- Basic UDI-DI
- B-06975445472016 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - 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
COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) Specimens: Nasopharynge… by Farmasino Medical 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-06975445472016 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Farmasino Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000026190
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 0b93c20a-4547-4f41-8d84-a2ffaaa88e6a 61 fields · synced Oct 6, 2026