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Sign in to claim this brandGENEA BIOMEDX PTY LTD
Australia·AU-MF-000035998
Last updated May 30, 2026
What GENEA BIOMEDX PTY LTD makes
The company produces media and solutions for in vitro fertilisation (IVF), including specialised culture media such as Gems Cleavage Medium, Gems Blastocyst Medium, and Gems Fertilisation Medium, as well as single-use storage containers like the Geri Water Bottle. It also offers embryo-assessment software for assisted reproduction, such as Geri Software Connect and Assess 2.0, alongside procedure-specific dishes like the Geri Dish and oocyte retrieval buffers. Additional products include warming sets for embryo handling and irrigation solutions for medical use.
These devices are classified under EU Medical Device Regulation as Class II and Class IIa, with regulatory listings in the EUDAMED database, FDA’s 510(k) premarket notification process, and FDA’s Unique Device Identification (UDI) system. The manufacturer is based in Australia and adheres to these international regulatory frameworks for its assisted reproduction and medical irrigation products.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Australia
- Address
- 321, Kent Street , Sydney, Australia
- Website
- www.geneabiomedx.com/
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Bekezela Ngwenya
- EUDAMED SRN
- AU-MF-000035998
- FDA FEI Number
- —
- DUNS Number
- 752103403
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gems Cleavage Medium | CLM-50 | FDA UDI | Class II | Active |
| Gems Blastocyst Medium | BLM-50 | FDA UDI | Class II | Active |
| Geri Water Bottle | GERI-WAT-01 | FDA UDI | Class II | Active |
| Gems Geri Medium | ONE-20 | FDA UDI | Class II | Active |
| Gems Fertilisation Medium | FEM-50 | FDA UDI | Class II | Active |
| Gems Cleavage Medium | CLM-20 | FDA UDI | Class II | Active |
| Gems Blastocyst Medium | BLM-20 | FDA UDI | Class II | Active |
| Geri Software Connect and Assess 2.0 | GERI-SCA-05 | FDA UDI | Class II | Active |
| Gems Geri Medium | ONE-50 | FDA UDI | Class II | Active |
| Oocyte Retrieval Buffer | ORB-50 | FDA UDI | Class II | Active |
| Gems Warming Set | WRM-01 | FDA UDI | Class II | Active |
| Geri Dish | GERI-DSH-20 | FDA UDI | Class II | Active |
| Oocyte Retrieval Buffer | ORB-20 | FDA UDI | Class II | Active |
| Geri Connect Server (including software) | GERI-GCS-01 | FDA UDI | Class II | Active |
| Gems VitBase | VBS-20 | FDA UDI | Class II | Active |
| Gems Fertilisation Medium | FEM-20 | FDA UDI | Class II | Active |
| Geri Software Connect and Assess 1.3 | GERI-SCA-04 | FDA UDI | Class II | Active |
| Gems Vitrification Set | VIT-01 | FDA UDI | Class II | Active |
| Geri Embryo Incubator and Geri Dish | K171736 | FDA 510(k) | Class II | Active |
| Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | K161261 | FDA 510(k) | Class II | Active |
| Geri Embryo Incubator and Geri Dish | K180304 | FDA 510(k) | Class II | Active |
| Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | K180188 | FDA 510(k) | Class II | Active |
| Gems Vitrification Set, Gems Warming Set | K162409 | FDA 510(k) | Class II | Active |
| Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | K170498 | FDA 510(k) | Class II | Active |
| Geri Instrument | GERI-INS-01 | EUDAMEDFDA UDI | Class IIa | Active |
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