FDA Registration
Active
🇫🇷 France
CRYO BIO SYSTEM
Reg #: 3003244268
·
FEI: 3003244268
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CRYO BIO SYSTEM
- Registration Number
- 3003244268
- FEI Number
- 3003244268
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZI NO 1 EST
- City
- Saint Ouen sur Iton Orne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K002595
Owner / Operator
- Firm Name
- CRYO BIO SYSTEM
- Operator Number
- 9042657
- Address
- ZI No 1 EST, --
- City
- Saint Ouen sur Iton
- State
- Orne
- Postal Code
- 61300
- Country
- FR
- Correspondent
- Priscilla Chapelier
US Agent
- Business Name
- IMV TECHNOLOGIES USA
- Contact Name
- ERIC SALONEN
- Address
- 9501 Louisiana Ave N, Suite 300
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- Country
- US
- [email protected]
- Phone
- 763 4881881
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Freezer | JRM | Class 1 | Clinical Chemistry | No | 2020-10-16 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2007-12-05 |
| Accessory, Assisted Reproduction, Exempt | PUB | Class 2 | Obstetrics/Gynecology | No | 2020-10-02 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2020-12-17 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2010-11-26 |
Proprietary Names
CBS Integral HSV Vitrification Workstation
CBS Straw System
CBS High Security Tube
CBS Sterile Filling Nozzle
CBS NANO Digitcool Controlled Rate Freezer
CBS SYMS Machine Sterile Nozzles
HSV Straw
High-Security Vitrification (HSV) Kit
Establishment Types
Manufacture Medical Device