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TSH CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CME0302Model AutoLumo analyzerRef CME0305
Identity
- Trade Name
- TSH CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCME0302 EUDAMEDCME0305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150908577 EUDAMED06942359541381 EUDAMED
- Basic UDI-DI
- 697015090000003GN EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE 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
TSH 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 | 697015090000003GN | 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 420eac0c-6b2e-4931-89dc-4e172123811a 61 fields · synced Aug 4, 2026
- EUDAMED 044e2e0e-75b9-40a6-8e64-b0fcde539082 61 fields · synced May 18, 2026