Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003244268

FEI Number

3003244268

Entity Name

CRYO BIO SYSTEM

City/State/Country

Saint Ouen sur Iton Orne, FR

Establishment Address

ZI NO 1 EST, Saint Ouen sur Iton Orne 61300, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CRYO BIO SYSTEM (Owner Number: 9042657)

Owner / Operator Contact Address

ZI No 1 EST, --, Saint Ouen sur Iton, FR-61 61300, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRM	Freezer	Clinical Chemistry	Class 1	862.2050	2020-10-16
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2007-12-05
PUB	Accessory, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6120	2020-10-02
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2020-12-17

Official Correspondent

Priscilla Chapelier

US Agent Details

ERIC SALONEN Business: IMV TECHNOLOGIES USA Email: ESALONEN@IMVUSA.COM Phone: (763) 4881881

Related Public Records

Same Entity

CRYO BIO SYSTEM

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Similar Registrations

Registration Number	Establishment Name	Location
3018228712	Regen Suppliers LLC	Scottsdale, AZ, US
3017858437	Elcold Frysere. Hobro ApS	Hobro Nordjylland, DK
3019916040	NUVE SANAYI MALZEMELERI IMALAT VE TICARET A.S.	ANKARA, TR
3030063003	Currie Medical, Inc.	Norfolk, VA, US
3018783057	RAC MEDICAL SOLUTIONS	Bruceton, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003244268. Last updated year: 2026. Please use registration number 3003244268 when referencing this establishment in official correspondence.