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Automatic Hematology Analyzer LS-6 Lysing Reagent
EUDAMEDClass A (EU MDR)
Ref BL2201226Model 500 mL×1, 500 mL×2, 1000 mL×1, 1000 mL×2Ref BL2202226
Identity
- Trade Name
- Automatic Hematology Analyzer LS-6 Lysing Reagent EUDAMED
- Device Name
- Automatic Hematology Analyzer LS-6 Lysing Reagent EUDAMED
- Model / Reference
- 500 mL×1, 500 mL×2, 1000 mL×1, 1000 mL×2 EUDAMEDBL2201226 EUDAMEDBL2202226 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617468639 EUDAMED06950617468653 EUDAMED
- Basic UDI-DI
- 69506174BL2202267A EUDAMED
- Direct Marketing DI
- 06950617468639 EUDAMED06950617468653 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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 LS-6 Lysing Reagent 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 | 69506174BL2202267A | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED c4d9d7c8-5400-4061-becd-a3d06881a2bb 61 fields · synced Jun 20, 2026
- EUDAMED 1e8320fc-0196-4180-bc52-4bc4c2021d75 61 fields · synced Jun 20, 2026