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Automatic Chemiluminescence Analyzer
EUDAMEDClass A (EU MDR)
Ref EIM9401015Model i 800； i 820； i 6000； i 8000； i 9000
Identity
- Trade Name
- Automatic Chemiluminescence Analyzer EUDAMED
- Device Name
- Automatic Chemiluminescence Analyzer EUDAMED
- Model / Reference
- i 800； i 820； i 6000； i 8000； i 9000 EUDAMEDEIM9401015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168355510 EUDAMED
- Basic UDI-DI
- 69721683511039T EUDAMED
- Direct Marketing DI
- 06972168355510 EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Chemiluminescence Analyzer by Maccura Medical Instrument Co., Ltd. — Class A — 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 | 69721683511039T | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 914e2609-190a-4a9a-81c2-a06be191c837 61 fields · synced Jun 19, 2026