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Monkeypox virus Nucleic Acid Rapid Detection Kit(colloidal gold)
EUDAMEDClass IVD General (EU MDR)
Ref XC98
Identity
- Device Name
- Monkeypox virus Nucleic Acid Rapid Detection Kit(colloidal gold) EUDAMED
- Model / Reference
- XC98 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500354 EUDAMED
- Basic UDI-DI
- B-06937044500354 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Monkeypox virus Nucleic Acid Rapid Detection Kit(colloidal gold) by Ningbo HEALTH Gene Technologies 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-06937044500354 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 6af4f504-fcc1-45da-b02f-f020542c6192 61 fields · synced Aug 4, 2026