Identity
- Trade Name
- Bioda EUDAMED
- Device Name
- Novel Coronavirus(COVID-19）Antigen Test Kit(Colloidal gold) EUDAMED
- Model / Reference
- / EUDAMED2 people/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971223290070 EUDAMED
- Basic UDI-DI
- 69712232900525L EUDAMED
- EMDN Code
- W02050101 NUCLEIC ACID HYBRIDIZATION UNITS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Bioda by Bioda Diagnostics (Wuhan) Co., Ltd — Class A — 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 | 69712232900525L | Class A | Active |
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Manufacturer
- Manufacturer
- Bioda Diagnostics (Wuhan) Co., Ltd
- EUDAMED SRN
- CN-MF-000018803
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9ae07931-919d-478c-a166-9343a6aee6b0 61 fields · synced Jul 17, 2026