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Osteocalcin CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMS0103Model AutoLumo analyzerRef CMS0105Ref CMS0101
Identity
- Trade Name
- Osteocalcin CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMS0103 EUDAMEDCMS0105 EUDAMEDCMS0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359542265 EUDAMED06942359542289 EUDAMED06975577171740 EUDAMED
- Basic UDI-DI
- 697015090000045H6 EUDAMED
- EMDN Code
- W0102060311 OSTEOCALCINE 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
Osteocalcin 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 | 697015090000045H6 | 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 c6a7efb4-b04d-4073-a3b4-8ef5ab0ddd78 61 fields · synced Jul 30, 2026
- EUDAMED 3f478da7-55e4-414f-bd71-2020817df390 61 fields · synced May 19, 2026
- EUDAMED 4facd8a4-a9fd-4038-bdd5-0a7395f626af 61 fields · synced May 19, 2026