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Hematology Analyzer LYSE
EUDAMEDClass IVD General (EU MDR)
Ref /Model Model：5LDA，Specification：4LModel Model：5LDS，Packing Specifications：500ml×2Model Model：3LHD，Packing Specifications： 500ml×4Model Model：5LH，Specification：200mLModel Model：5LDB，Specification：200mLModel Model：5LH，Specification：500mL×4Model Model：3LHD，Packing Specifications：500mlModel Model：5LDA，Specification：1000mL×4Model Model：5LHS，Packing Specifications：200ml×2Model Model：5LDS，Packing Specifications：200mlModel Model：5LDA，Specification：1000mLModel Model：5LDA，Specification：200mLModel Model：3LHD，Packing Specifications：500ml×2Model Model：5LDB，Specification：500mL×4Model Model：5LH，Specification：500mLModel Model：5LDS，Packing Specifications：500ml
Identity
- Trade Name
- Hematology Analyzer LYSE EUDAMED
- Device Name
- Hematology Analyzer LYSE EUDAMED
- Model / Reference
- Model：5LDA，Specification：4L EUDAMED/ EUDAMEDModel：5LDS，Packing Specifications：500ml×2 EUDAMEDModel：3LHD，Packing Specifications： 500ml×4 EUDAMEDModel：5LH，Specification：200mL EUDAMEDModel：5LDB，Specification：200mL EUDAMEDModel：5LH，Specification：500mL×4 EUDAMEDModel：3LHD，Packing Specifications：500ml EUDAMEDModel：5LDA，Specification：1000mL×4 EUDAMEDModel：5LHS，Packing Specifications：200ml×2 EUDAMEDModel：5LDS，Packing Specifications：200ml EUDAMEDModel：5LDA，Specification：1000mL EUDAMEDModel：5LDA，Specification：200mL EUDAMEDModel：3LHD，Packing Specifications：500ml×2 EUDAMEDModel：5LDB，Specification：500mL×4 EUDAMEDModel：5LH，Specification：500mL EUDAMEDModel：5LDS，Packing Specifications：500ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429026429 EUDAMED06945429026795 EUDAMED06945429026733 EUDAMED06945429026351 EUDAMED06945429026436 EUDAMED06945429026375 EUDAMED06945429026719 EUDAMED06945429026412 EUDAMED06945429026757 EUDAMED06945429026771 EUDAMED06945429026405 EUDAMED06945429026399 EUDAMED06945429026726 EUDAMED06945429026450 EUDAMED06945429026368 EUDAMED06945429026788 EUDAMED
- Basic UDI-DI
- B-06945429026429 EUDAMEDB-06945429026795 EUDAMEDB-06945429026733 EUDAMEDB-06945429026351 EUDAMEDB-06945429026436 EUDAMEDB-06945429026375 EUDAMEDB-06945429026719 EUDAMEDB-06945429026412 EUDAMEDB-06945429026757 EUDAMEDB-06945429026771 EUDAMEDB-06945429026405 EUDAMEDB-06945429026399 EUDAMEDB-06945429026726 EUDAMEDB-06945429026450 EUDAMEDB-06945429026368 EUDAMEDB-06945429026788 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Iceland EUDAMEDIreland 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-06945429026429 | 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 (16)
- EUDAMED 0ade123f-e7e2-4d7b-8e50-fa659476f1e2 61 fields · synced Oct 6, 2026
- EUDAMED dd8085d7-7b4b-430d-a586-3552f3da053c 61 fields · synced May 16, 2026
- EUDAMED a6a66abe-4328-43d7-a9f4-1b3837500ece 61 fields · synced May 16, 2026
- EUDAMED ea2c84f9-2b7c-47e1-8911-26203d71731a 61 fields · synced May 16, 2026
- EUDAMED 3d182cf6-f924-4001-b3db-2576473f979f 61 fields · synced May 17, 2026
- EUDAMED 8160b6fe-3ef9-44af-85f9-2c1778f07e93 61 fields · synced May 17, 2026
- EUDAMED fdc2cfdf-d10a-4956-aa8b-1f5ad6205ae3 61 fields · synced May 17, 2026
- EUDAMED 2819ac9b-cb1e-409b-a863-ebb7392f5315 61 fields · synced May 17, 2026
- EUDAMED be8d30d6-a7e6-4e59-be5f-073c447b845f 61 fields · synced May 19, 2026
- EUDAMED 7cb74173-868d-4c9f-b774-5b92a00b3635 61 fields · synced May 19, 2026
- EUDAMED 15371eb1-5355-4a8d-9c9c-b86c32143a65 61 fields · synced May 19, 2026
- EUDAMED c543f8c7-2278-479a-ab1f-22d4f2820118 61 fields · synced May 19, 2026
- EUDAMED 4ad70f32-9fdb-4419-acfa-c809016adf75 61 fields · synced May 19, 2026
- EUDAMED 186d2cdc-c279-4a21-8852-9281b1e2a52d 61 fields · synced May 19, 2026
- EUDAMED cca449c8-f34c-4095-b3ac-efa429e904df 61 fields · synced May 19, 2026
- EUDAMED dec1a3bf-ab93-4cea-8095-7627f401c101 61 fields · synced May 19, 2026