Identity
- Trade Name
- XR-10 EUDAMED
- Device Name
- XR-Series Automated Hematology Analyzer EUDAMED
- Model / Reference
- CF730361 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CF730361U8 EUDAMED
- Basic UDI-DI
- B-CF730361U8 EUDAMED
- EMDN Code
- W02029080 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Xr-10 by Sysmex Corporation — 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-CF730361U8 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (1)
- EUDAMED bc5d9f06-6cb4-43e2-8042-97e3987290f2 61 fields · synced May 23, 2026