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B19 IgG CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMK1105Model AutoLumo analyzerRef CMK1110
Identity
- Trade Name
- B19 IgG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMK1105 EUDAMEDCMK1110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359552417 EUDAMED06975577178299 EUDAMED
- Basic UDI-DI
- 697015090000275HR EUDAMED
- EMDN Code
- W0105040609 PARVOVIRUS B 19 EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Türkiye EUDAMEDItaly 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
B19 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 | 697015090000275HR | 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 (2)
- EUDAMED 39c20a28-9c1c-4f66-8c14-5d93925de76c 61 fields · synced Jul 11, 2026
- EUDAMED 2cc519a0-df6c-4d62-ae7a-6a4cad78ec80 61 fields · synced May 18, 2026