cNeuro cDAT

by Combinostics Oy

Ref cNeuro cDAT, 2

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

19 Feb 2030

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier SGS FIMKO OY

510(k) K233908↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	NumberFI22/871878	Date10 Oct 2025Issued	StatusActive expires 19 Feb 2030
United States	GUDID listing GUDID	Number06430070845012 UDI-DI	Date25 Feb 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) 510(k)	NumberK233908	Date1 Jul 2024Issued	StatusActive
European Union	CE/MDR EUDAMED	Number64300708450285 Basic UDI-DI	Date28 Dec 2023Registered	StatusActive

Certificates

1 certificate · EUDAMED

FI22/871878 Active Supplemented

Quality management system EU MDR

Certifier

SGS FIMKO OY 0598

Issued
10 Oct 2025

Expires
19 Feb 2030

Valid from
11 Oct 2025

Reason
Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name: Radiology DICOM image processing application software
Model / Reference: cNeuro cDAT, 2, 1.0.x

Primary DI / UDI-DI: 06430070845012, 06430070845029
Basic UDI-DI: 64300708450285
Direct Marketing DI: 06430070845029
510(k) Number: K233908
FDA Product Code: LLZ
EMDN Code: V92 Medical device software - not included in other classes
GMDN Term: Radiology DICOM image processing application software

Device Class: Class IIa EUDAMED
Class II GUDID
Regulation Number: 892.2050
Special Device Type: Software
EU market of registration: Finland
Austria
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device Class	EUDAMED Class IIa	GUDID Class II

Manufacturer details

EUDAMED SRN: FI-MF-000011968

Other devices from Combinostics Oy

cNeuro cMRI

Class IIa
cNeuro cPET

Class II
cNeuro cDSI

Class IIa

Properties

Prescription Use
Premarket Exempt NoGUDIDYesGUDID

Other properties (22)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No