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Monkeypox Virus Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJC70115NW-25T
Identity
- Trade Name
- Monkeypox Virus Real Time PCR Kit EUDAMED
- Device Name
- Monkeypox Virus Real Time PCR Kit EUDAMED
- Model / Reference
- YJC70115NW-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973342003449 EUDAMED
- Basic UDI-DI
- B-06973342003449 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 Real Time PCR Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06973342003449 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 89e95632-52a7-46f2-a32f-34da1f61a1f8 61 fields · synced Jun 18, 2026