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Flu A/B + COVID-19 Antigen Combo Test Cassette Kit
EUDAMEDClass IVD General (EU MDR)
Ref R218T020B1C0Ref R218T020B0C0
Identity
- Device Name
- Flu A/B + COVID-19 Antigen Combo Test Cassette Kit EUDAMED
- Model / Reference
- R218T020B1C0 EUDAMEDR218T020B0C0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895474115 EUDAMED06970895474207 EUDAMED
- Basic UDI-DI
- B-06970895474115 EUDAMEDB-06970895474207 EUDAMED
- EMDN Code
- W0105040618 BOCAVIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Flu A/B + COVID-19 Antigen Combo Test Cassette Kit by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — 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-06970895474115 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 240193f9-91b0-4f36-b614-8f7888b31989 61 fields · synced Jul 22, 2026
- EUDAMED 61d0a5f8-3646-40f6-9078-9cbc858e3869 61 fields · synced May 17, 2026