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Hematology Analyzer LYSE
EUDAMEDClass A (EU MDR)
Ref 6500-PA00009Model 3LHD, 5LDA, 5LDB, 5LH, 5LDS, 5LHS, 6LD, 6LH, 6LN
Identity
- Device Name
- Hematology Analyzer LYSE EUDAMED
- Model / Reference
- 3LHD, 5LDA, 5LDB, 5LH, 5LDS, 5LHS, 6LD, 6LH, 6LN EUDAMED6500-PA00009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978066778857 EUDAMED
- Basic UDI-DI
- 697806677SE001NN EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Hematology Analyzer LYSE by Shenzhen CoooSeee Biomedical 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 | 697806677SE001NN | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen CoooSeee Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000045646
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 1b357e3a-88e3-46b3-a376-be79783f5f3b 61 fields · synced Jul 9, 2026