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Rotavirus A B C Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref YJC50301NW-25TRef YJC50301NW-50T
Identity
- Trade Name
- Rotavirus A B C Real Time PCR Kit EUDAMED
- Device Name
- Rotavirus A B C Real Time PCR Kit EUDAMED
- Model / Reference
- YJC50301NW-25T EUDAMEDYJC50301NW-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-YJC50301NW-25T28 EUDAMEDD-YJC50301NW-50T28 EUDAMED
- Basic UDI-DI
- B-YJC50301NW-25T28 EUDAMEDB-YJC50301NW-50T28 EUDAMED
- EMDN Code
- W0105040506 ROTAVIRUS - NA REAGENTS 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
Rotavirus A B C 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-YJC50301NW-25T28 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 16506ef8-c3dc-44ab-bde1-2b2722517428 61 fields · synced Jul 11, 2026
- EUDAMED 0d3cb900-168f-4818-98bf-a342e5140c7f 61 fields · synced May 18, 2026