← Back to catalogue
BSP-800 Automated Hematology Smear Slide Processor
EUDAMEDClass A (EU MDR)
Ref 3019711Model BSP-800
Identity
- Trade Name
- BSP-800 Automated Hematology Smear Slide Processor EUDAMED
- Device Name
- Automated Hematology Smear Slide Processor EUDAMED
- Model / Reference
- BSP-800 EUDAMED3019711 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794575692 EUDAMED
- Basic UDI-DI
- 69257945W0202059002D0QR EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
BSP-800 Automated Hematology Smear Slide Processor by Dirui Industrial 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 | 69257945W0202059002D0QR | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 937ceece-0ce9-489a-b218-24a51ce5e5d6 61 fields · synced Jul 19, 2026