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Automatic Hematology Analyzer LH-5 Lysing Reagent A
EUDAMEDClass A (EU MDR)
Ref BL2201006Model 500 mL×1; 500 mL×4
Identity
- Trade Name
- Automatic Hematology Analyzer LH-5 Lysing Reagent A EUDAMED
- Device Name
- Automatic Hematology Analyzer LH-5 Lysing Reagent A EUDAMED
- Model / Reference
- 500 mL×1; 500 mL×4 EUDAMEDBL2201006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617415299 EUDAMED
- Basic UDI-DI
- 69506174BL2200066S EUDAMED
- Direct Marketing DI
- 06950617415299 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 LH-5 Lysing Reagent 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 | 69506174BL2200066S | 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 5cf2a690-1e63-458e-83fa-10922c0f578d 61 fields · synced Oct 6, 2026