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EmbryoViewer

by Vitrolife A/S

Ref 16622

EmbryoViewer (16622) 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 (2 earlier submissions) and listed in FDA GUDID since 16 Apr 2026 (UDI-DI 05712714676222), 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

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05712714676222 UDI-DI Date16 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5712714SWA-01S4 Basic UDI-DI 05712714676222UDI-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· +2 more in the status table
  • FDA GUDID UDI-DI 05712714676222 listed 16 Apr 2026 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K113075
  2. Cleared FDA 510(k) K133712
  3. Cleared FDA 510(k) K173264
  4. Registered EUDAMED 5712714SWA-01S4
  5. Listed FDA GUDID 05712714676222

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  • Withdrawn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

Generic name
Assisted reproduction embryo-assessment software
Device name
EmbryoViewer version 7 (incl. Guided Annotation)
Model / Ref / Catalog
16622, 7
Primary DI / UDI-DI
05712714676222
Basic UDI-DI
5712714SWA-01S4
Direct marketing DI
05712714676222
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
16622
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

Related devices

Category: Assisted reproduction vitrification carrier

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)