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Sectra Digital Pathology Module 4.2

by Sectra AB

Part of a family of 6 devices: see the family page

Ref 155

Sectra Digital Pathology Module 4.2 is a device classified as Class IIa in the EU and Class II in the US made by Sectra AB, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 735009281Pathology_AppKK) and listed in FDA GUDID since 9 Apr 2025 (UDI-DI 07350092810593), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735009281Pathology_AppKK Basic UDI-DI 07350092810593UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350092810593 UDI-DI Date9 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735009281Pathology_AppKK registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 07350092810593 listed 9 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350092810593
  2. Registered EUDAMED 735009281Pathology_AppKK

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Sectra Digital Pathology Module 4.2 EUDAMED
Sectra Digital Pathology Module GUDID
Generic name
Pathology information system
Model / reference
155 EUDAMED
4.2 GUDID
Primary DI / UDI-DI
07350092810593
Basic UDI-DI
735009281Pathology_AppKK
Direct marketing DI
07350092810593
FDA product code
QKQ
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Pathology information system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.3700
Special device type
Software
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
155
GUDID
4.2
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.

Related devices

Category: Pathology information system

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Sectra AB

See all devices from Sectra AB →

Properties

  • Measuring function
  • Prescription use
Other properties (23, all answered No)