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tIgE CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQ0602Model Autolumo AnalyzerRef CMQ0603
Identity
- Trade Name
- tIgE CLIA Microparticles EUDAMED
- Device Name
- tIgE CLIA Microparticles EUDAMED
- Model / Reference
- Autolumo Analyzer EUDAMEDCMQ0602 EUDAMEDCMQ0603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150906603 EUDAMED06942359547260 EUDAMED
- Basic UDI-DI
- 697015090000053H5 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
tIgE CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class B — 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 | 697015090000053H5 | Class B | 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 6a36f275-1552-4c51-a16f-e687e86a1903 61 fields · synced Jul 12, 2026
- EUDAMED 4f313540-77dc-4917-b11c-87ed863767da 61 fields · synced May 18, 2026