← Back to catalogue
Calcitonin CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMS0605Model AutoLumo analyzerRef CMS0601Ref CMS0603
Identity
- Trade Name
- Calcitonin CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMS0605 EUDAMEDCMS0601 EUDAMEDCMS0603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359542487 EUDAMED06975577171948 EUDAMED06942359542463 EUDAMED
- Basic UDI-DI
- 697015090000048HC EUDAMED
- EMDN Code
- W0102060301 CALCITONIN EUDAMED
Classification
- Device Class
- Class C 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
Calcitonin 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 | 697015090000048HC | 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 (3)
- EUDAMED 8a71d7e4-858a-40e2-add2-a2a48ea7c61e 61 fields · synced Jul 16, 2026
- EUDAMED b9ff4a60-0235-4b9b-9611-39b566ab2e2c 61 fields · synced May 17, 2026
- EUDAMED 5be5f73e-18ba-4ef0-bedb-992323c9ac5c 61 fields · synced May 19, 2026