Data / Medical devices / France / Cryo Bio System
Cryo Bio System: FDA-registered device maker in Saint Ouen sur Iton Orne, France, 2 510(k) clearances
Cryo Bio System is registered with the FDA (registration 3003244268) in Saint Ouen sur Iton Orne, France. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 6, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003244268
- Address
- Zi No 1 Est, Saint Ouen sur Iton Orne, France, 61300
- Owner or operator
- CRYO BIO SYSTEM (9042657)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- CBS High Security Tube, CBS Integral HSV Vitrification Workstation, CBS NANO Digitcool Controlled Rate Freezer, CBS SYMS Machine Sterile Nozzles, CBS Sterile Filling Nozzle, CBS Straw System, HSV Straw, High-Security Vitrification (HSV) Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | 2 | Manufacturer | accessdata.fda.gov |
| Accessory, Assisted Reproduction, Exempt | PUB | 2 | Manufacturer | accessdata.fda.gov |
| Freezer | JRM | 1 | Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 6, 2010 | K092398 | HSV STRAW | MQK | Substantially Equivalent | Cryo Bio System | accessdata.fda.gov |
| November 17, 2000 | K002595 | CBS STRAW | MQG | Substantially Equivalent | Cryo Bio System | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Assisted Reproduction, Exempt
- All makers of Labware, Assisted Reproduction
- All makers of Freezer
- All makers of Accessory, Assisted Reproduction
- All makers of Micro Pipette
Updated October 6, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.