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EmbryoSlide

by Vitrolife A/S

Ref FT-S-ES-D

EmbryoSlide (FT-S-ES-D) is an assisted reproduction procedure dish (EU MDR Class IIa; FDA Class II; FDA product code MQK, Labware, Assisted Reproduction) made by Vitrolife A/S, registered in EUDAMED on 7 Dec 2022 (Basic UDI-DI 5712714DISH-01M2), cleared under FDA 510(k) K150961 on 4 Dec 2015 and listed in FDA GUDID since 26 Aug 2016 (UDI-DI 05712714663505), 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) K150961

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5712714DISH-01M2 Basic UDI-DI 05712714663505UDI-DIDate7 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05712714663505 UDI-DI Date26 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK150961 Date4 Dec 2015IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5712714DISH-01M2 registered 7 Dec 2022 Active
  • FDA 510(k) K150961 decided 4 Dec 2015 Active
  • FDA GUDID UDI-DI 05712714663505 listed 26 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150961
  2. Listed FDA GUDID 05712714663505
  3. Registered EUDAMED 5712714DISH-01M2

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  • Withdrawn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
EmbryoSlide EUDAMED
EmbryoSlide culture dish GUDID
Generic name
Assisted reproduction procedure dish
Model / Ref / Catalog
FT-S-ES-D
Primary DI / UDI-DI
05712714663505
Basic UDI-DI
5712714DISH-01M2
510(k) Number
FDA product code
MQK
EMDN code
U080206 Culture plates for assisted reproduction
GMDN term
Assisted reproduction procedure dish
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.6160
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
DK-MF-000001892

Similar devices in this category

Other devices filed under CULTURE PLATES FOR ASSISTED REPRODUCTION.

Other devices from Vitrolife A/S

See all devices from Vitrolife A/S →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)