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EmbryoScope+

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 16401

by Vitrolife A/S

Identity

Trade Name
EmbryoScope+ EUDAMEDFDA UDI
Generic Name
Assisted reproduction incubator/microscope camera system FDA UDI
Device Name
EmbryoScope+ EUDAMED
EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator. The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator. The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images. FDA UDI
Model / Reference
16401 EUDAMED
ES-P1 FDA UDI
Description
EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator. The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator. The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images. FDA UDI

Identifiers

Catalog Number
16401 FDA UDI
Primary DI / UDI-DI
05712714604010 EUDAMEDFDA UDI
Basic UDI-DI
5712714INC-01KD EUDAMED
Direct Marketing DI
05712714604010 EUDAMED
510(k) Number
K173264 FDA UDI
FDA Product Code
MQK FDA UDI
MTX FDA UDI
MQG FDA UDI
EMDN Code
U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
GMDN Term
Assisted reproduction incubator/microscope camera system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
884.6160 FDA UDI
884.6190 FDA UDI
884.6120 FDA UDI
Market of Registration
Denmark EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 50 Kilogram FDA UDI
Height — 50 Centimeter FDA UDI
Depth — 60 Centimeter FDA UDI
Width — 55 Centimeter FDA UDI

Category: Assisted reproduction vitrification carrier

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

Similar devices

Also classified as Assisted reproduction vitrification carrier.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

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

Sources (2)

  • EUDAMED 1cb8b8fd-a14b-407a-8b6e-b3162c6567a3 61 fields · synced Jun 18, 2026
  • FDA UDI f0bd1999-a8f2-4f62-a7ea-792f8d5f23ac 38 fields · synced May 30, 2026