← Back to catalogue
Monkeypox Virus Antigen Detection Kit (Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-OT079GModel 20 tests/kitRef HWTS-OT079EModel 1 test/kit
Identity
- Trade Name
- Monkeypox Virus Antigen Detection Kit (Immunochromatography) EUDAMED
- Device Name
- Monkeypox Virus Antigen Detection Kit (Immunochromatography) EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDHWTS-OT079G EUDAMED1 test/kit EUDAMEDHWTS-OT079E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849368581 EUDAMED06974849368567 EUDAMED
- Basic UDI-DI
- B-06974849368581 EUDAMEDB-06974849368567 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 Antigen Detection Kit (Immunochromatography) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974849368581 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
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 4a2f622d-bd8d-4584-b30f-5d936f02bc09 61 fields · synced Jul 10, 2026
- EUDAMED 0fa8d416-b71a-4b7d-ba22-af023a844ac6 61 fields · synced May 18, 2026