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Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-OT145BModel 5 tests/kitRef HWTS-OT145AModel 1 test/kit
Identity
- Trade Name
- Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) EUDAMED
- Device Name
- Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) EUDAMED
- Model / Reference
- 5 tests/kit EUDAMEDHWTS-OT145B EUDAMED1 test/kit EUDAMEDHWTS-OT145A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849368604 EUDAMED06974849368598 EUDAMED
- Basic UDI-DI
- B-06974849368604 EUDAMEDB-06974849368598 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974849368604 | 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 (2)
- EUDAMED 97cd1a74-e272-43e5-ba04-9ed959643843 61 fields · synced Jul 21, 2026
- EUDAMED d788485b-15e7-488f-995e-df6821cc24ab 61 fields · synced May 16, 2026