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Monkeypox virus Nucleic Acid Rapid Detection Kit(Fluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref XC101
Identity
- Device Name
- Monkeypox virus Nucleic Acid Rapid Detection Kit(Fluorescence) EUDAMED
- Model / Reference
- XC101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500361 EUDAMED
- Basic UDI-DI
- B-06937044500361 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(Fluorescence) 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-06937044500361 | 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 02b828c1-63d4-4521-a6a1-f5a08ad3ddcd 61 fields · synced Jul 15, 2026