EmbryoSlide

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref FT-S-ES-D

by Vitrolife A/S

Identity

Trade Name: EmbryoSlide EUDAMED
EmbryoSlide culture dish FDA UDI
Generic Name: Assisted reproduction procedure dish FDA UDI
Device Name: EmbryoSlide+ EUDAMED
The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device. The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm. FDA UDI
Model / Reference: FT-S-ES-D EUDAMEDFDA UDI
Description: The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device. The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm. FDA UDI

Identifiers

Catalog Number: FT-S-ES-D FDA UDI
Primary DI / UDI-DI: 05712714663505 EUDAMEDFDA UDI
Basic UDI-DI: 5712714DISH-01M2 EUDAMED
510(k) Number: K150961 FDA UDI
FDA Product Code: MQK FDA UDI
EMDN Code: U080206 CULTURE PLATES FOR ASSISTED REPRODUCTION EUDAMED
GMDN Term: Assisted reproduction procedure dish FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 884.6160 FDA UDI
Market of Registration: Denmark EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

EmbryoSlide by Vitrolife A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	5712714DISH-01M2	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Vitrolife A/S
EUDAMED SRN: DK-MF-000001892

Sources (2)

EUDAMED 7112f303-824b-463e-86de-f2ebe3caacd9 61 fields · synced Jun 18, 2026
FDA UDI de82aa59-8768-4a72-ba85-8f1467f8af51 37 fields · synced May 30, 2026