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Group A streptococcus Rapid test Kit
EUDAMEDClass IVD General (EU MDR)
Ref 012124-20-111
Identity
- Trade Name
- Group A streptococcus Rapid test Kit EUDAMED
- Device Name
- Group A streptococcus Rapid test Kit EUDAMED
- Model / Reference
- 012124-20-111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-012124L3 EUDAMED
- Basic UDI-DI
- B-012124L3 EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Group A streptococcus Rapid test Kit by Jiangsu Medomics Medical Technology 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-012124L3 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Medomics Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030226
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 2c4e4076-48df-454e-aa5c-43542cd2fc63 61 fields · synced Jun 18, 2026