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TRAb CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CME1001Model AutoLumo AnalyzerRef CME1003Ref CME1005
Identity
- Trade Name
- TRAb CLIA Microparticles EUDAMED
- Device Name
- TRAb CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo Analyzer EUDAMEDCME1001 EUDAMEDCME1003 EUDAMEDCME1005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975577178169 EUDAMED06942359541763 EUDAMED06942359541787 EUDAMED
- Basic UDI-DI
- 697015090000118H8 EUDAMED
- EMDN Code
- W0102100302 TSH RECEPTOR ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
TRAb 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 | 697015090000118H8 | 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 (3)
- EUDAMED bb0711e7-82b6-4fc2-9c87-ca66e1cc3f9f 61 fields · synced Jul 18, 2026
- EUDAMED fcacd27e-80f0-4215-a7c2-bc0a2808bc12 61 fields · synced May 17, 2026
- EUDAMED 380b8d89-ba84-478b-bdd3-b32ea520c302 61 fields · synced May 19, 2026