Identity
- Trade Name
- Geri Software Connect and Assess 2.0 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-05 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
- 09348265003086 FDA UDI
- 510(k) Number
- K180188 FDA UDI
- FDA Product Code
- MQG FDA UDIMTX FDA UDIMQK FDA UDI
- GMDN Term
- Assisted reproduction embryo-assessment software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6120 FDA UDI884.6190 FDA UDI884.6160 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 2.0 by Genea Biomedx Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction embryo-assessment software.
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genea Biomedx Pty Ltd
Sources (1)
- FDA UDI 35a073df-e1e6-4cea-8a7a-8a3613f9eec2 34 fields · synced May 30, 2026