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Anti-TG CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CME0608Model AutoLumo analyzerRef CME0801Ref CME0603
Identity
- Trade Name
- Anti-TG CLIA Microparticles EUDAMEDTG CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCME0608 EUDAMEDCME0801 EUDAMEDCME0603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359506359 EUDAMED06970150906351 EUDAMED06942359541862 EUDAMED
- Basic UDI-DI
- 697015090000022GS EUDAMED697015090000024GW EUDAMED
- EMDN Code
- W0102100303 THYROGLOBULIN AUTOANTIBODY EUDAMEDW01020408 THYROGLOBULIN EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
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
Anti-TG 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 | 697015090000022GS | 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 42781712-fa50-49a3-8355-85a6ed69ba15 61 fields · synced Jul 20, 2026
- EUDAMED 2261a457-0db6-4c7b-a603-194eabdd2e6d 61 fields · synced May 18, 2026
- EUDAMED 8966a297-ab3c-466b-b892-34d1dac1c793 61 fields · synced May 18, 2026