Identity
- Trade Name
- SP-50 EUDAMED
- Device Name
- Automated Hematology Slide Preparation Unit EUDAMED
- Model / Reference
- BX765805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987562468041 EUDAMED
- Basic UDI-DI
- 4987562SP-505H EUDAMED
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Sp-50 by Sysmex Corporation — 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 | 4987562SP-505H | Class A | Active |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (1)
- EUDAMED 945fbb45-ec46-4229-baaa-4a44bed41448 61 fields · synced Jun 18, 2026