Identity
- Trade Name
- Geri Instrument EUDAMEDGeri Embryo Incubator FDA UDI
- Generic Name
- Assisted reproduction heater/incubator FDA UDI
- Device Name
- Geri Instrument EUDAMEDThe Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings. FDA UDI
- Model / Reference
- GERI-INS-01 EUDAMEDFDA UDI
- Description
- The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348265003000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09348265003000 EUDAMED
- 510(k) Number
- K171736 FDA UDI
- FDA Product Code
- MQK FDA UDIMQG FDA UDIMTX FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Assisted reproduction heater/incubator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6160 FDA UDI884.6120 FDA UDI884.6190 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Geri Instrument by Genea Biomedx Pty Ltd — Class IIa — MDD, 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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09348265003000 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Genea Biomedx Pty Ltd
- EUDAMED SRN
- AU-MF-000035998
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (2)
- EUDAMED 1d31c313-7c67-411e-bb75-6c314e5fb70c 61 fields · synced Jun 19, 2026
- FDA UDI 055c2f58-079e-42f5-9788-255ede47f67b 34 fields · synced May 30, 2026