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Monkeypox Virus Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJC70115NW-50TRef YJC70115NW-25TModel YJC70204NW-25T
Identity
- Trade Name
- Monkeypox Virus Real Time PCR Kit EUDAMED
- Device Name
- Monkeypox Virus Real Time PCR Kit EUDAMEDMonkeypox Virus Genotyping Real Time PCR Kit EUDAMED
- Model / Reference
- YJC70115NW-50T EUDAMEDYJC70204NW-25T EUDAMEDYJC70115NW-25T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973342003456 EUDAMEDD-YJC70115NW-25T5F EUDAMED
- Basic UDI-DI
- B-06973342003456 EUDAMEDB-YJC70115NW-25T5F EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMEDW0105040599 VIROLOGY - NA REAGENTS - OTHER 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
EUDAMEDEUDAMED
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-06973342003456 | 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 (2)
- EUDAMED fbac4387-f5b8-41cb-81fd-57f54b51ced3 61 fields · synced Jul 16, 2026
- EUDAMED a633d49a-84a6-41a7-92d8-2c61edd537db 61 fields · synced May 17, 2026