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Cardiac Markers Control
EUDAMEDClass C (EU MDR)
Ref ZKD0307Model AutoLumo analyzerRef ZKD0207
Identity
- Trade Name
- Cardiac Markers Control EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZKD0307 EUDAMEDZKD0207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359507585 EUDAMED06942359507547 EUDAMED
- Basic UDI-DI
- 697015090000354HN EUDAMED
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS 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
Cardiac Markers Control 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 | 697015090000354HN | 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 (2)
- EUDAMED 4fb164ef-3dcc-45e8-81f2-129382cf18a9 61 fields · synced Jun 20, 2026
- EUDAMED 0f95187a-0020-4db9-ad75-a30d13983abf 61 fields · synced May 17, 2026