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M-5leo(ⅱ) Lyse
EUDAMEDClass A (EU MDR)
Ref 105-011730-00Model Please see UDI-DIs for details
Identity
- Trade Name
- M-5LEO(Ⅱ) LYSE EUDAMED
- Device Name
- Hematology Analyzer Reagent EUDAMED
- Model / Reference
- Please see UDI-DIs for details EUDAMED105-011730-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904093147 EUDAMED
- Basic UDI-DI
- 69449040XQSJ-003BM-5S**VC 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
M-5leo(ⅱ) Lyse by Shenzhen Mindray Bio-Medical Electronics 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 | 69449040XQSJ-003BM-5S**VC | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 49767735-6cf8-4bfb-9586-a4fa1e51562f 61 fields · synced Jun 18, 2026