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β-CTX CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMS0810Model AutoLumo analyzerRef CMS0805Ref CMS0803
Identity
- Trade Name
- β-CTX CLIA Microparticles EUDAMED
- Device Name
- β-CTX CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMS0810 EUDAMEDCMS0805 EUDAMEDCMS0803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359525374 EUDAMED06942359542685 EUDAMED06942359542661 EUDAMED
- Basic UDI-DI
- 697015090000137HC EUDAMED
- EMDN Code
- W0102060304 CROSS-LINKED C-TELOPEPTIDES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
β-CTX 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 | 697015090000137HC | 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 be518cd5-1677-488e-ae91-4f6b34ee04f1 61 fields · synced Aug 3, 2026
- EUDAMED 7588dfe3-3417-4667-a357-c4e60a3378b9 61 fields · synced May 17, 2026
- EUDAMED 712c6725-4ab8-4655-bc4f-c7b45859118b 61 fields · synced May 18, 2026