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Automatic Hematology Analyzer CC-5 Cell Clean A
EUDAMEDClass A (EU MDR)
Ref EBL2201009Model 2 mL×6
Identity
- Trade Name
- Automatic Hematology Analyzer CC-5 Cell Clean A EUDAMED
- Device Name
- Automatic Hematology Analyzer CC-5 Cell Clean A EUDAMED
- Model / Reference
- 2 mL×6 EUDAMEDEBL2201009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617415367 EUDAMED
- Basic UDI-DI
- 69506174BL2200096Y EUDAMED
- Direct Marketing DI
- 06950617415367 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) 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
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
Automatic Hematology Analyzer CC-5 Cell Clean A by Maccura Biotechnology 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 | 69506174BL2200096Y | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 180b729b-f01d-47ad-a7a0-3bcc4cdb19b3 61 fields · synced Jun 18, 2026