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RSV Antigen Fluorescent Rapid Test Cassette (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref FCRSV-502a
Identity
- Trade Name
- RSV Antigen Fluorescent Rapid Test Cassette (Swab) EUDAMED
- Device Name
- RSV Antigen Fluorescent Rapid Test Cassette (Swab) EUDAMED
- Model / Reference
- FCRSV-502a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FCRSV-502aHGKS EUDAMED
- Basic UDI-DI
- B-FCRSV-502aHGKS EUDAMED
- EMDN Code
- W0105040605 RESPIRATORY SYNCYTIAL VIRUS (RSV) 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
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
RSV Antigen Fluorescent Rapid Test Cassette (Swab) 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-FCRSV-502aHGKS | 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 (1)
- EUDAMED d539596b-1b5e-4a6c-b368-318c9bd7b033 61 fields · synced Jul 25, 2026