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T3 CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CME0103Model AutoLumo analyzerRef CME0105Ref CME0102
Identity
- Trade Name
- T3 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCME0103 EUDAMEDCME0105 EUDAMEDCME0102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359541466 EUDAMED06942359541480 EUDAMED06970150908553 EUDAMED
- Basic UDI-DI
- 697015090000001GJ EUDAMED
- EMDN Code
- W01020405 TRIIODOTHYRONINE 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
T3 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 | 697015090000001GJ | 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 6943775a-f3cf-4947-a7b9-8e1b892c0ab8 61 fields · synced Jul 29, 2026
- EUDAMED 9e0fb527-7e23-4099-a0a4-2673fb13d4c2 61 fields · synced May 17, 2026
- EUDAMED 7b4d0233-e5d4-4b9a-b371-0a4c288718a6 61 fields · synced May 19, 2026