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SARS-CoV-2 Antigen Rapid Tests for Self-Testing
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref COV-S23004H/COV-S23006HModel Device 1 person/box
Identity
- Trade Name
- SARS-CoV-2 Antigen Rapid Tests for Self-Testing EUDAMED
- Device Name
- SARS-CoV-2 Antigen Rapid Tests for Self-Testing EUDAMED
- Model / Reference
- Device 1 person/box EUDAMEDCOV-S23004H/COV-S23006H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804807276 EUDAMED
- Basic UDI-DI
- B-06952804807276 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Antigen Rapid Tests for Self-Testing by Assure Tech. (hangzhou) Co., Ltd. — Class IVD devices for self-testing — 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-06952804807276 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 31934f5d-88f9-4b33-86fb-5a99c816ce83 61 fields · synced Jul 11, 2026