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Hematology Analysis Automation Workstation
EUDAMEDClass A (EU MDR)
Ref EBL9201011Model LABAS F 9000 X
Identity
- Trade Name
- Hematology Analysis Automation Workstation EUDAMED
- Device Name
- Hematology Analysis Automation Workstation EUDAMED
- Model / Reference
- LABAS F 9000 X EUDAMEDEBL9201011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168354148 EUDAMED
- Basic UDI-DI
- 69721683520059Z EUDAMED
- Direct Marketing DI
- 06972168354148 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
Hematology Analysis Automation Workstation 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 | 69721683520059Z | 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 6f1fc585-7047-44a8-9e63-fb30c7327460 61 fields · synced Oct 8, 2026