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Strep A Rapid Test
EUDAMEDClass B (EU MDR)
Ref A4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240Model Strip, DeviceRef A46310120
Identity
- Trade Name
- Strep A Rapid Test Device EUDAMED
- Device Name
- Strep A Rapid Test EUDAMED
- Model / Reference
- Strip, Device EUDAMEDA4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240 EUDAMEDA46310120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804825638 EUDAMED06952804809720 EUDAMED
- Basic UDI-DI
- 69528048A463101ZT EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Malta EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Strep A Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69528048A463101ZT | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 6d97e48b-73e2-4054-a6cc-9892ddac0403 61 fields · synced Jul 16, 2026
- EUDAMED 6d97e48b-73e2-4054-a6cc-9892ddac0403-1 61 fields · synced Jun 10, 2026
- EUDAMED 99490c9c-90a9-43a4-88b2-5ad287180174 61 fields · synced Jul 11, 2026