Identity
- Trade Name
- EmbryoScope EUDAMEDEmbryoScope time-lapse incubator FDA UDI
- Generic Name
- Assisted reproduction incubator/microscope camera system FDA UDI
- Device Name
- EmbryoScope EUDAMEDThe EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development. FDA UDI
- Model / Reference
- ESD20000 EUDAMEDFDA UDI
- Description
- The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development. FDA UDI
Identifiers
- Catalog Number
- ESD20000 FDA UDI
- Primary DI / UDI-DI
- 05712714603013 EUDAMEDFDA UDI
- Basic UDI-DI
- 5712714INC-02KF EUDAMED
- Direct Marketing DI
- 05712714603013 EUDAMED
- FDA Product Code
- 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 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
Category: Assisted reproduction vitrification carrier
EmbryoScope by Vitrolife A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 5712714INC-02KF | 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 3484686b-d15d-4324-90da-9b3df683db21 61 fields · synced Aug 1, 2026
- FDA UDI c55e751c-e75e-4951-85c7-51e54c04bebc 36 fields · synced May 30, 2026