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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (E…
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-OT033AModel 50 tests/kit
Identity
- Trade Name
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Plasmodium EUDAMED
- Device Name
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Plasmodium EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-OT033A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366037 EUDAMED
- Basic UDI-DI
- B-06974849366037 EUDAMED
- EMDN Code
- W0105050209 PLASMODIUM (MALARIA) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (E… by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD…
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-06974849366037 | Class IVD General | 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 918624d8-7255-48e3-b92b-30c9ed7f6efc 61 fields · synced Jun 9, 2026