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M.Pneumonia Antigen Rapid Test Device
EUDAMEDClass IVD General (EU MDR)
Ref K681416D
Identity
- Trade Name
- M.Pneumonia Antigen Rapid Test Device EUDAMED
- Model / Reference
- K681416D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792053182 EUDAMED
- Basic UDI-DI
- B-06971792053182 EUDAMED
- EMDN Code
- W0105010801 MYCOPLASMA ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class IVD General 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
M.Pneumonia Antigen Rapid Test Device by Hangzhou Realy Tech 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-06971792053182 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 0d775c19-2a36-457c-9600-7cdb4297631b 61 fields · synced Jul 11, 2026