Identity
- Trade Name
- RespiGUARD4plex EUDAMED
- Device Name
- RespiGUARD4plex EUDAMED
- Model / Reference
- AB0024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760322820072 EUDAMED
- Basic UDI-DI
- 376032282DINFSCFRRK EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
RespiGUARD4plex by Appolon Bioteck — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 376032282DINFSCFRRK | Class B | Active |
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Manufacturer
- Manufacturer
- Appolon Bioteck
- EUDAMED SRN
- FR-MF-000022234
Sources (1)
- EUDAMED 318e5c24-a97a-42ea-a530-817760b1e7eb 61 fields · synced Jul 13, 2026