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StrokeViewer
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref N/AModel Version 4510(k) K231570
Identity
- Trade Name
- StrokeViewer EUDAMED
- Device Name
- StrokeViewer EUDAMED
- Model / Reference
- Version 4 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720299502345 EUDAMED
- Basic UDI-DI
- 87202995023STRKVWRBD EUDAMED
- 510(k) Number
- K231570 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
StrokeViewer by Nico-Lab B.V. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231570 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 87202995023STRKVWRBD | Class IIb | Active |
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Manufacturer
- Manufacturer
- NICo-Lab B.V.
- EUDAMED SRN
- NL-MF-000005895
Sources (2)
- EUDAMED ba53f4b6-c067-4813-9bda-fd0990ae680d 61 fields · synced Jul 11, 2026
- FDA 510(k) K231570 24 fields · synced May 18, 2026