← Back to catalogue
S100 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB2310Model AutoLumo analyzerRef CMB2305
Identity
- Trade Name
- S100 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB2310 EUDAMEDCMB2305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359525572 EUDAMED06942359550611 EUDAMED
- Basic UDI-DI
- 697015090000133H4 EUDAMED
- EMDN Code
- W0102039012 EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Türkiye EUDAMEDItaly 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
EUDAMEDEUDAMED
S100 CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class C — 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 | 697015090000133H4 | Class C | 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 (2)
- EUDAMED 828bc562-296e-4d74-bd6d-b9682d62d57b 61 fields · synced Jul 19, 2026
- EUDAMED e104dffc-1c12-4014-9e89-8fa1d5787168 61 fields · synced May 18, 2026