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Hematology Analyzer LYSE
EUDAMEDClass IVD General (EU MDR)
Ref /Model Model：5LDB，Specification：500mL
Identity
- Trade Name
- Hematology Analyzer LYSE EUDAMED
- Model / Reference
- Model：5LDB，Specification：500mL EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429026443 EUDAMED
- Basic UDI-DI
- B-06945429026443 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Iceland 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
No
EUDAMED
Hematology Analyzer LYSE by Shenzhen Comen Medical Instruments 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-06945429026443 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c0c44b31-0fcc-4b3b-9733-7fe31d588f2b 61 fields · synced Jun 19, 2026