Identity
- Trade Name
- BOIRON EUDAMED
- Device Name
- COVID-19/Grippe Rapid Antigen Test EUDAMED
- Model / Reference
- B6061403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861680480 EUDAMED
- Basic UDI-DI
- B-06973861680480 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Boiron by Suny (Xiamen) Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06973861680480 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suny (Xiamen) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035201
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED cfa422dc-0733-47ad-aa21-cfa48fdeceb3 61 fields · synced Oct 7, 2026