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JCV/BKV nucleic acid digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref "Model: JB01-Q24; Specification: 24 Tests Model: JB01-Y24; Specification: 24 Tests"Model JB01-Q24,JB01-Y24Ref 13786-1Model JB01-Q24Ref 13786-2Model JB01-Y24
Identity
- Trade Name
- JCV/BKV nucleic acid digital PCR detection kit EUDAMED
- Device Name
- JCV/BKV nucleic acid digital PCR detection kit EUDAMED
- Model / Reference
- JB01-Q24,JB01-Y24 EUDAMED"Model: JB01-Q24; Specification: 24 Tests Model: JB01-Y24; Specification: 24 Tests" EUDAMEDJB01-Q24 EUDAMED13786-1 EUDAMEDJB01-Y24 EUDAMED13786-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626346 EUDAMED06974689627183 EUDAMED
- Basic UDI-DI
- B-06974689626346 EUDAMEDB-06974689627183 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMEDAustria 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
JCV/BKV nucleic acid digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — 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-06974689626346 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 7d52b79c-6a8f-4812-9284-0a41c2d3ece5 61 fields · synced Jul 9, 2026
- EUDAMED 7d52b79c-6a8f-4812-9284-0a41c2d3ece5-1 61 fields · synced Jun 9, 2026
- EUDAMED 7370b332-7562-40a1-9df7-ed40f10ec4d1 61 fields · synced Jun 19, 2026
- EUDAMED 658e239e-1ed1-49f0-8d52-6be546be1985 61 fields · synced Jul 9, 2026