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Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref E-OD-0022-02-96
Identity
- Trade Name
- Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit EUDAMED
- Device Name
- Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit EUDAMED
- Model / Reference
- E-OD-0022-02-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042229688 EUDAMED
- Basic UDI-DI
- B-06971042229688 EUDAMED
- EMDN Code
- W0105040205 CMV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France 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
Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit by Shanghai Zj Bio-Tech Co., Ltd. — Class IVD Annex II List B — 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-06971042229688 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 57e37e35-c9c1-49a5-8f37-f1d8cd39229e 61 fields · synced Jun 17, 2026