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AutoLumo HS-cTnT Calibrators
EUDAMEDClass C (EU MDR)
Ref CA100701Model AutoLumo analyzer
Identity
- Trade Name
- AutoLumo HS-cTnT Calibrators EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCA100701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975577177865 EUDAMED
- Basic UDI-DI
- 697015090000260HC EUDAMED
- EMDN Code
- W0102152204 CARDIAC MARKER STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class C 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
AutoLumo HS-cTnT Calibrators 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 | 697015090000260HC | Class C | 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 (1)
- EUDAMED e78b33dc-d386-4e7b-a67b-5e1fd1c908ac 61 fields · synced Jul 31, 2026