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EudemonTM AIO800
EUDAMEDClass A (EU MDR)
Ref HWTS-EQ007Model HWTS 1600P,HWTS 1600S
Identity
- Trade Name
- EudemonTM AIO800 EUDAMED
- Device Name
- Easy Amp Real-time Fluorescence Isothermal Detection System (HWTS 1600) EUDAMED
- Model / Reference
- HWTS 1600P,HWTS 1600S EUDAMEDHWTS-EQ007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849368666 EUDAMED
- Basic UDI-DI
- 697484936W02050199W7 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
EudemonTM AIO800 by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class A — 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 | 697484936W02050199W7 | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 12291f72-40d2-4d8e-9e48-0db8934ea595 61 fields · synced Jul 21, 2026