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Neowise

by CEFLA s.c.

Ref NEOWISEModel Medical Device Software

Neowise is a medical device (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by CEFLA s.c., cleared under FDA 510(k) K260716 on 4 May 2026, registered in EUDAMED on 15 Oct 2025 (Basic UDI-DI 803383793IMSWASMDB001K8) and listed in FDA GUDID since 11 May 2026 (UDI-DI 08033837938835), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K260716↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08033837938835 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK260716 Date4 May 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number803383793IMSWASMDB001K8 Basic UDI-DI 08033837938835UDI-DIDate15 Oct 2025RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K260716 decided 4 May 2026 Active
  • EUDAMED Basic UDI-DI 803383793IMSWASMDB001K8 registered 15 Oct 2025 Active
  • FDA GUDID UDI-DI 08033837938835 listed 11 May 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 803383793IMSWASMDB001K8
  2. Cleared FDA 510(k) K260716
  3. Listed FDA GUDID 08033837938835

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
Neowise EUDAMED
no brand GUDID
Generic name
Dental clinical assessment support radiology software
Model / Ref / Catalog
Medical Device Software, NEOWISE, 7XPD
Primary DI / UDI-DI
08033837938835
Basic UDI-DI
803383793IMSWASMDB001K8
Direct marketing DI
08033837938835
510(k) Number
FDA product code
LLZ
EMDN code
Z11039092 Various radiodiagnostic and interventional instruments - medical device software
GMDN term
Dental clinical assessment support radiology software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IT-MF-000009228

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from CEFLA s.c.

See all devices from CEFLA s.c. →

Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)