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Macro & Micro-Test Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref HWTS-EQ003Model HWTS IF 100
Identity
- Trade Name
- Macro & Micro-Test Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Macro & Micro-Test Fluorescence Reader EUDAMED
- Model / Reference
- HWTS IF 100 EUDAMEDHWTS-EQ003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366860 EUDAMED
- Basic UDI-DI
- 697484936W0201020201DG EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS 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
Macro & Micro-Test Fluorescence Immunoassay Analyzer by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697484936W0201020201DG | 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 c7488f57-8000-4c87-b670-a4f2a6e1cc41 61 fields · synced Jun 19, 2026