← Back to catalogue
Anti-TPO CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CME0705Model AutoLumo analyzerRef CME0703Ref CME0701
Identity
- Trade Name
- Anti-TPO CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCME0705 EUDAMEDCME0703 EUDAMEDCME0701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359541985 EUDAMED06942359541961 EUDAMED06970150906313 EUDAMED
- Basic UDI-DI
- 697015090000023GU EUDAMED
- EMDN Code
- W0102100301 THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES 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
Anti-TPO 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 | 697015090000023GU | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED c92b9a19-634a-4da7-9242-f13ed3770831 61 fields · synced Jul 31, 2026
- EUDAMED 9f735c9d-1cfe-48b9-a844-92fdf4bff368 61 fields · synced May 18, 2026
- EUDAMED 7c815dc1-e9cd-4e47-a912-717152580cc0 61 fields · synced May 18, 2026