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StrongStep® Strep B Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 500090Model 20 Tests/box
Identity
- Trade Name
- StrongStep® Strep B Antigen Rapid Test EUDAMED
- Device Name
- Strep B Antigen Rapid Test EUDAMED
- Model / Reference
- 20 Tests/box EUDAMED500090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181850433 EUDAMED
- Basic UDI-DI
- B-06973181850433 EUDAMED
- EMDN Code
- W0105011101 STREPTOCOCCAL DIRECT ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
StrongStep® Strep B Antigen Rapid Test by Nanjing Liming Bio-products Co. Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: SARS-CoV-2 Antigen Rapid Test for Saliva
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-06973181850433 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Liming Bio-products Co. Ltd
- EUDAMED SRN
- CN-MF-000041298
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED a73e58fb-5013-442b-bfbe-1da6b784dd1a 61 fields · synced Jul 28, 2026