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SARS-CoV-2 Antigen Test Cassette
EUDAMEDClass IVD General (EU MDR)
Ref R220T001B0C0Ref R220T01SB0C0
Identity
- Device Name
- SARS-CoV-2 Antigen Test Cassette EUDAMEDSARS-CoV-2 Antigen Test Cassette EUDAMED
- Model / Reference
- R220T001B0C0 EUDAMEDR220T01SB0C0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895474009 EUDAMED06970895472487 EUDAMED
- Basic UDI-DI
- B-06970895474009 EUDAMEDB-06970895472487 EUDAMED
- EMDN Code
- W0105040618 BOCAVIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Croatia EUDAMEDGreece 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
SARS-CoV-2 Antigen Test Cassette by Jiangsu Mole Bioscience 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-06970895474009 | 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 4e736b35-e4b2-4e11-9bca-f409ae6e63b3 61 fields · synced Jul 31, 2026
- EUDAMED e0d305c6-b903-47b7-9966-9456e4428f83 61 fields · synced May 17, 2026