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Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplific…
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-OT200BModel 50 tests/kitRef HWTS-OT200DModel 48 tests/kitRef HWTS-OT200CModel 16 tests/kit
Identity
- Trade Name
- Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) EUDAMED
- Device Name
- Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-OT200B EUDAMED48 tests/kit EUDAMEDHWTS-OT200D EUDAMED16 tests/kit EUDAMEDHWTS-OT200C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849368659 EUDAMED06974849368635 EUDAMED06974849368628 EUDAMED
- Basic UDI-DI
- B-06974849368659 EUDAMEDB-06974849368635 EUDAMEDB-06974849368628 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - 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
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
Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplific… 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-06974849368659 | 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 (3)
- EUDAMED 54f917af-b39d-4260-b032-5c618e497b06 61 fields · synced Jul 19, 2026
- EUDAMED b3ccd46b-e7ec-440c-8b51-25b7b4c392ab 61 fields · synced May 17, 2026
- EUDAMED c09f6e8f-f19d-4901-855f-541a03fbec1f 61 fields · synced May 18, 2026