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EmbryoScope 8

by Vitrolife A/S 2 variants

Ref 16408

EmbryoScope 8 (16408), a medical device (EU MDR Class IIa; EMDN category devices for assisted reproduction) made by Vitrolife A/S, was registered in EUDAMED on 7 Dec 2022 (Basic UDI-DI 5712714INC-01KD) and cleared under FDA 510(k) K173264 on 11 May 2018; registry data as of 24 Oct 2026.

Active European Union and United States

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173264↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5712714INC-01KD Basic UDI-DI 05712714604089UDI-DIDate7 Dec 2022RegisteredStatusActive EUDAMED: not on the EU market
United StatesFDA 510(k) 510(k) NumberK173264 Date11 May 2018IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5712714INC-01KD registered 7 Dec 2022 Active
  • FDA 510(k) K173264 decided 11 May 2018 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K173264
  2. Registered EUDAMED 5712714INC-01KD

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  • Withdrawn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)

Device name
EmbryoScope+
Model / reference
16408
Primary DI / UDI-DI
05712714604089
Basic UDI-DI
5712714INC-01KD
Direct marketing DI
05712714604089
EMDN code
U080299 Devices for assisted reproduction - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Denmark

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

Other properties (14, all answered No)