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Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
EUDAMEDClass C (EU MDR)
Ref IS-FZ-064-25-CEModel 25 tests/kit ;Ref IS-FZ-064-50-CE
Identity
- Trade Name
- Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- 25 tests/kit ; EUDAMEDIS-FZ-064-25-CE EUDAMEDIS-FZ-064-50-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974677692537 EUDAMED06974677692544 EUDAMED
- Basic UDI-DI
- 6974677692537K9 EUDAMED
- Direct Marketing DI
- 06974677692537 EUDAMED06974677692544 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) by Shanghai BioGerm Medical Technology Co., Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6974677692537K9 | Class C | Active |
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Manufacturer
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018164
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED f3cce3b7-d0bd-440a-9b68-2293246c50dd 61 fields · synced Oct 7, 2026
- EUDAMED b5be7bbc-5cde-48aa-a1b0-75df271db155 61 fields · synced May 19, 2026