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Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assa…
EUDAMEDClass C (EU MDR)
Ref ICA2114-7
Identity
- Trade Name
- Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay) EUDAMED
- Device Name
- Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay) EUDAMED
- Model / Reference
- ICA2114-7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541564472 EUDAMED06974541564465 EUDAMED06974541564441 EUDAMED06974541564458 EUDAMED06974541564434 EUDAMED
- Basic UDI-DI
- 697454156017LA EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assa… by Bioteke Corporation (Wuxi) Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 697454156017LA | Class C | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (5)
- EUDAMED 4f162a75-c614-4c6a-b8f1-4664f5d0b302 61 fields · synced Oct 5, 2026
- EUDAMED c3b4400f-e8ba-46bb-899e-d36f06f02c5f 61 fields · synced May 17, 2026
- EUDAMED f5b4066d-7494-4a53-a648-6c0a403079c2 61 fields · synced May 18, 2026
- EUDAMED d2255cbd-8b1d-4acb-93c7-bd77c4aaaf07 61 fields · synced May 19, 2026
- EUDAMED 5ef9d27b-50d1-481e-974b-74e58f50c459 61 fields · synced May 19, 2026