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KIDScore D3

by Vitrolife A/S

Ref FT-KS-D3

KIDScore D3 (FT-KS-D3) is an assisted reproduction embryo-assessment software (EU MDR Class I; FDA Class II; FDA product code PBH, Embryo Image Assessment System, Assisted Reproduction) made by Vitrolife A/S, registered in EUDAMED on 5 Dec 2022 (Basic UDI-DI 5712714SWT-01W9), cleared under FDA 510(k) K182798 on 19 Jul 2019 and listed in FDA GUDID since 28 Nov 2019 (UDI-DI 05712714675317), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182798↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5712714SWT-01W9 Basic UDI-DI 05712714675317UDI-DIDate5 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05712714675317 UDI-DI Date28 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK182798 Date19 Jul 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5712714SWT-01W9 registered 5 Dec 2022 Active
  • FDA 510(k) K182798 decided 19 Jul 2019 Active
  • FDA GUDID UDI-DI 05712714675317 listed 28 Nov 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182798
  2. Listed FDA GUDID 05712714675317
  3. Registered EUDAMED 5712714SWT-01W9

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  • Withdrawn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

Generic name
Assisted reproduction embryo-assessment software
Device name
iDAScore
Model / Ref / Catalog
FT-KS-D3 EUDAMED
16531 GUDID
Primary DI / UDI-DI
05712714675317
Basic UDI-DI
5712714SWT-01W9
Direct marketing DI
05712714675317
510(k) Number
FDA product code
PBH
EMDN code
U080299 Devices for assisted reproduction - other
GMDN term
Assisted reproduction embryo-assessment software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.6195
Special device type
Software
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FT-KS-D3
GUDID
16531
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
DK-MF-000001892

Similar devices in this category

Other devices filed under DEVICES FOR ASSISTED REPRODUCTION - OTHER.

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Properties

  • Prescription use
Other properties (24, all answered No)