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Inflammation Markers Control
EUDAMEDClass C (EU MDR)
Ref ZK0401L201Model AutoLumo analyzerRef ZK0401L301Ref ZK0401L101
Identity
- Trade Name
- Inflammation Markers Control EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZK0401L201 EUDAMEDZK0401L301 EUDAMEDZK0401L101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359507400 EUDAMED06942359507448 EUDAMED06942359507363 EUDAMED
- Basic UDI-DI
- 697015090000355HQ EUDAMED
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Inflammation 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 | 697015090000355HQ | 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 (3)
- EUDAMED abbe515e-c14d-4431-bf04-5201d539a117 61 fields · synced Aug 3, 2026
- EUDAMED e020cefb-e1e5-4212-bc66-7787065a0ef5 61 fields · synced May 17, 2026
- EUDAMED 47a131a8-b445-4131-9811-7338e91082ef 61 fields · synced May 18, 2026