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COVID-19 Antigen Rapid Test Device
EUDAMEDClass IVD General (EU MDR)
Ref COV-S23Model Device 1 person/boxRef /
Identity
- Trade Name
- COVID-19 Antigen Rapid Test Device EUDAMED
- Device Name
- COVID-19 Antigen Rapid Test Device EUDAMEDCOVID 19 Rapid Test EUDAMED
- Model / Reference
- Device 1 person/box EUDAMEDCOV-S23 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804807238 EUDAMED06952804805890 EUDAMED
- Basic UDI-DI
- B-06952804807238 EUDAMEDB-06952804805890 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105090599 OTHER CORONAVIRUS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
COVID-19 Antigen Rapid Test Device by Assure Tech. (hangzhou) 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-06952804807238 | Class IVD General | 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 (2)
- EUDAMED 35623ce1-c2e8-41f5-8ab7-56378e2f5a5e 61 fields · synced Aug 2, 2026
- EUDAMED 601dc427-272b-4217-97c9-338bf115c832 61 fields · synced Aug 2, 2026