← Back to catalogue
Automated Hematology Analyzer Lyse
EUDAMEDClass A (EU MDR)
Ref XQ9013YModel MS-5LH
Identity
- Trade Name
- Automated Hematology Analyzer Lyse EUDAMED
- Device Name
- Automated Hematology Analyzer Lyse EUDAMED
- Model / Reference
- MS-5LH EUDAMEDXQ9013Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595746303 EUDAMED
- Basic UDI-DI
- 693659579013PG EUDAMED
- EMDN Code
- W0103010103 COMPLETE CELL COUNT EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Automated Hematology Analyzer Lyse by Medicalsystem 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 | 693659579013PG | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c14cbdbf-6ac6-413e-95a9-27d8a82ddff5 61 fields · synced Jun 18, 2026