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KIDScore D3
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref FT-KS-D3510(k) K182798
Identity
- Trade Name
- KIDScore D3 EUDAMEDFDA UDI
- Generic Name
- Assisted reproduction embryo-assessment software FDA UDI
- Device Name
- iDAScore EUDAMEDThe KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems. FDA UDI
- Model / Reference
- FT-KS-D3 EUDAMED16531 FDA UDI
- Description
- The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems. FDA UDI
Identifiers
- Catalog Number
- 16531 FDA UDI
- Primary DI / UDI-DI
- 05712714675317 EUDAMEDFDA UDI
- Basic UDI-DI
- 5712714SWT-01W9 EUDAMED
- Direct Marketing DI
- 05712714675317 EUDAMED
- 510(k) Number
- K182798 FDA UDI
- FDA Product Code
- PBH FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Assisted reproduction embryo-assessment software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6195 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
KIDScore D3 by Vitrolife A/S — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182798 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5712714SWT-01W9 | Class I | Active |
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Manufacturer
- Manufacturer
- Vitrolife A/S
- EUDAMED SRN
- DK-MF-000001892
Sources (3)
- EUDAMED 7c5f01a7-1774-438c-b97a-48f620b6bb3e 85 fields · synced Jun 18, 2026
- FDA UDI 7ae9164c-1b1b-4126-b22c-49c4b7510690 36 fields · synced May 30, 2026
- FDA 510(k) K182798 1 fields · synced May 18, 2026