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CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref /
Identity
- Trade Name
- CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold) EUDAMED
- Device Name
- CMV Cytomegalovirus Antibody IgM Rapid Test Kit(Colloidal Gold) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935091671904 EUDAMED
- Basic UDI-DI
- B-06935091671904 EUDAMED
- EMDN Code
- W0105099001 CMV - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany 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
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold) by Qingdao Hightop Biotech 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-06935091671904 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016890
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 81450090-9b2c-4e2a-bbb3-5df64ed72e85 61 fields · synced Jun 19, 2026