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HSV-2 IgG CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMK1002Model Autolumo analyzerRef CMK1003Ref CMK1005
Identity
- Trade Name
- HSV-2 IgG CLIA Microparticles EUDAMED
- Model / Reference
- Autolumo analyzer EUDAMEDCMK1002 EUDAMEDCMK1003 EUDAMEDCMK1005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150908898 EUDAMED06942359552295 EUDAMED06942359552318 EUDAMED
- Basic UDI-DI
- 697015090000108H5 EUDAMED
- EMDN Code
- W0105040309 HSV 2 IGG EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
HSV-2 IgG CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697015090000108H5 | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 37785cab-fa07-4ada-b865-9a5f2133191e 61 fields · synced Jul 17, 2026
- EUDAMED c3c503ec-0bb5-4de7-9418-41a276e46677 61 fields · synced May 18, 2026
- EUDAMED 0d5e9aa3-5df3-4608-936b-9dc07e4938f5 61 fields · synced May 19, 2026