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Automatic Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref EBL9201002Model F 560
Identity
- Trade Name
- Automatic Hematology Analyzer EUDAMED
- Device Name
- Automatic Hematology Analyzer EUDAMED
- Model / Reference
- F 560 EUDAMEDEBL9201002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168355640 EUDAMED
- Basic UDI-DI
- B-06972168355640 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Slovenia 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
Automatic Hematology Analyzer by Maccura Medical Instrument Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06972168355640 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2af3b96d-8428-4601-ad85-058f50e4b83b 61 fields · synced Jun 19, 2026