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Hematology Analysis Automation Workflow System
EUDAMEDClass A (EU MDR)
Ref EBL9205011Model LABAS F 2000
Identity
- Trade Name
- Hematology Analysis Automation Workflow System EUDAMED
- Device Name
- Hematology Analysis Automation Workflow System EUDAMED
- Model / Reference
- LABAS F 2000 EUDAMEDEBL9205011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168353707 EUDAMED
- Basic UDI-DI
- 6972168352007A5 EUDAMED
- Direct Marketing DI
- 06972168353707 EUDAMED
- EMDN Code
- W02060102 AUTOMATED SAMPLE TRANSPORT SYSTEMS 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 Workflow System 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 | 6972168352007A5 | 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 ac146546-6f73-4c70-b22e-517c9f1ff864 61 fields · synced Oct 6, 2026