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Automated Hematology Analyzer Diluent
EUDAMEDClass A (EU MDR)
Ref XQ9001YModel DIL-A
Identity
- Trade Name
- Automated Hematology Analyzer Diluent EUDAMED
- Device Name
- Automated Hematology Analyzer Diluent EUDAMED
- Model / Reference
- DIL-A EUDAMEDXQ9001Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970291980791 EUDAMED
- Basic UDI-DI
- 693659579001P9 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 Diluent 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 | 693659579001P9 | Class A | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 77a58e50-2526-4df6-bc1c-0c0b497b39e1 61 fields · synced Jun 18, 2026