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Herpes Simplex Virus Type I/II Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref JC60202NW-24TRef JC60202NW-48T
Identity
- Trade Name
- Herpes Simplex Virus Type I/II Real Time PCR Kit EUDAMED
- Device Name
- Herpes Simplex Virus Type I/II Real Time PCR Kit EUDAMED
- Model / Reference
- JC60202NW-24T EUDAMEDJC60202NW-48T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-JC60202NW-24TTE EUDAMEDD-JC60202NW-48TU4 EUDAMED
- Basic UDI-DI
- B-JC60202NW-24TTE EUDAMEDB-JC60202NW-48TU4 EUDAMED
- EMDN Code
- W0105040311 HSV - 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
Yes
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
Herpes Simplex Virus Type I/II Real Time PCR Kit by Jiangsu Bioperfectus Technologies Co., Ltd. — 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-JC60202NW-24TTE | 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 256e09d1-d09e-45cc-bb79-281a76729af4 61 fields · synced Jul 21, 2026
- EUDAMED 69ce7ac7-9c8e-401f-924a-fc76f795e14c 61 fields · synced May 18, 2026