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ES server version 7

by Vitrolife A/S

Ref 16612

ES server version 7 (16612) is an assisted reproduction embryo-assessment software (EU MDR Class I; FDA Class II; FDA product code MQG, Accessory, Assisted Reproduction) made by Vitrolife A/S, registered in EUDAMED on 2 Sep 2022 (Basic UDI-DI 5712714SWA-01S4), cleared under FDA 510(k) K173264 on 11 May 2018 and listed in FDA GUDID since 16 Apr 2026 (UDI-DI 05712714676123), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173264

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05712714676123 UDI-DI Date16 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5712714SWA-01S4 Basic UDI-DI 05712714676123UDI-DIDate2 Sep 2022RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK173264 Date11 May 2018IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5712714SWA-01S4 registered 2 Sep 2022 Active
  • FDA 510(k) K173264 decided 11 May 2018 Active
  • FDA GUDID UDI-DI 05712714676123 listed 16 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173264
  2. Registered EUDAMED 5712714SWA-01S4
  3. Listed FDA GUDID 05712714676123

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ES server version 7 EUDAMED
ES server GUDID
Generic name
Assisted reproduction embryo-assessment software
Device name
EmbryoViewer version 7 (incl. Guided Annotation)
Model / Ref / Catalog
16612, 7
Primary DI / UDI-DI
05712714676123
Basic UDI-DI
5712714SWA-01S4
Direct marketing DI
05712714676123
510(k) Number
FDA product code
MQG
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
884.6120
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
16612
GUDID
7
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.

Other devices from Vitrolife A/S

See all devices from Vitrolife A/S →

Properties

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