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Mycoplasma Pneumoniae Antigen Rapid Test Device
EUDAMEDClass B (EU MDR)
Ref A46710Model A46710120,A46710220
Identity
- Trade Name
- Mycoplasma Pneumoniae Antigen Rapid Test Device EUDAMED
- Device Name
- Mycoplasma Pneumoniae Antigen Rapid Test Device EUDAMED
- Model / Reference
- A46710120,A46710220 EUDAMEDA46710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832063 EUDAMED
- Basic UDI-DI
- 69528048A4671002Q EUDAMED
- EMDN Code
- W0105090109 STREP. PNEUMONIAE - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
Mycoplasma Pneumoniae Antigen Rapid Test Device 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 | 69528048A4671002Q | 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 (1)
- EUDAMED 0b2f1806-c9ca-4498-8cb0-cb5cd8577d76 61 fields · synced Jun 18, 2026