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RapidFor™ SARS-CoV-2 Rapid Antigen Test (Nasal)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref VSCD02ST01Ref VSCD02ST05Ref VSCD02ST02
Identity
- Trade Name
- RapidFor™ SARS-CoV-2 Rapid Antigen Test (Nasal) EUDAMED
- Device Name
- RapidFor™ SARS-CoV-2 Rapid Antigen Test Kit (Nasal) EUDAMED
- Model / Reference
- VSCD02ST01 EUDAMEDVSCD02ST05 EUDAMEDVSCD02ST02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548250001 EUDAMED08683548250025 EUDAMED08683548250018 EUDAMED
- Basic UDI-DI
- B-08683548250001 EUDAMEDB-08683548250025 EUDAMEDB-08683548250018 EUDAMED
- EMDN Code
- W0105040619,W0105099099 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
RapidFor™ SARS-CoV-2 Rapid Antigen Test (Nasal) by Vitrosens Biotechnology Inc. — Class IVD devices for self-testing — 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-08683548250001 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (3)
- EUDAMED f8d6321b-a2aa-486d-ba2e-6b0be1f9adbc 61 fields · synced Oct 6, 2026
- EUDAMED 5720e86b-b518-4881-85c6-a04313c39c5b 61 fields · synced May 18, 2026
- EUDAMED 3a569999-8c0b-4767-b51c-1ee7e2c112a9 61 fields · synced May 19, 2026