Identity
- Trade Name
- Geri Software Connect and Assess 1.3 FDA UDI
- Generic Name
- Assisted reproduction embryo-assessment software FDA UDI
- Device Name
- Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations. FDA UDI
- Model / Reference
- GERI-SCA-04 FDA UDI
- Description
- Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348265003079 FDA UDI
- 510(k) Number
- K180188 FDA UDI
- FDA Product Code
- MQK FDA UDIMTX FDA UDIMQG FDA UDI
- GMDN Term
- Assisted reproduction embryo-assessment software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 FDA UDI884.6190 FDA UDI884.6120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Assisted reproduction embryo-assessment software
Geri Software Connect and Assess 1.3 by Genea Biomedx Pty Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction embryo-assessment software.
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genea Biomedx Pty Ltd
Sources (2)
- FDA UDI 28ebe508-0693-4615-b01c-867245231b92 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026