IONISOS

FDA Device Registration & Listing · CHAUMESNIL Grand Est, FR · Registration 3003775072

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003775072
FEI Number
3003775072
Entity Name
IONISOS
City/State/Country
CHAUMESNIL Grand Est, FR
Establishment Address
ZI, CHAUMESNIL Grand Est 10500, FR
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
EPIONE BIDCO (Owner Number: 10042490)
Owner / Operator Contact Address
415 allee de Frenes, bat Squale, LIMONEST, FR-69 69760, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

High security Tube Cinesteam® CBS Straw System CBS High Security Tube Leucolab LCG2 Leukoreduction System For Red Blood Cells FRYDMAN®ULTRASOFT ULTRASOFT FRYDMAN® SET ECHO WITH GUIDE FRYDMAN®ULTRASOFT ECHO MOCK CATHETER FRYDMAN MEMORY STANDARD CLASSIC ULTRASOFT MOCK 18 CM/23 CM ULTRASOFT MOCK 18 CM INVENTCATH ECO CLASSIC ULTRASOFT 18 CM/23 CM ECHOGYN®EMBRYOVIEW M 18 CM/23 CM STYLET FOR FRYDMAN®ULTRASOFT & FRYDMAN® ULTRASOFT echo ECHOGYN®EMBRYOVIEW M MOCK 18 CM FULL ECHO®PRO FRYDMAN® CLASSIC 4.5/5.5 ULTRASOFT FRYDMAN®SET ECHO SHORT FRYDMAN®SET ULTRASOFT FRYDMAN ® SET ECHO MOCK FRYDMAN®SOFT WITH GUIDE FULL ECHO®23 CM ULTRASOFT FRYDMAN® SET AVEC WIH GUIDE T.D.T® SET ULTRASOFT FRYDMAN ® SET MOCK NasalCEASE and BleedCEASE OPS CLASSIC WITHOUT VALVE OOCYTE RETRIEVAL NEEDLE30CM G17 OOCYTE RETRIEVAL NEEDLE 25CM G17 OPS A.R.T. OF C.C.D. ® WITHOUT VALVE OPS A.R.T. OF C.C.D. ®WITH VALVE OVO A.R.T. OF C.C.D.® NEEDLE 30CM G17 OPS CLASSIC WITH VALVE RESORBA Synthetic Bone Leucolab LCG2 Leukoreduction Systems for AS-1 And AS-3 Red Blood Cells Leucolab LCG2 Leukoreduction Systems For AS-1 Red Blood Cells, Leucolab LCG2 Leukoreduction Systems For AS-1, AS-3 And AS-5 Red Blood Cells STANDARD INTRA UTERINE INSEMINATION CANNULA SPIRETTE® INTRA UTERINE INSEMINATION CANNULA WITH MANDREL MEMORY INTRA UTERINE INSEMINATION CANNULA SMALL GENITOR® INTRA UTERINE INSEMINATION CANNULA MUCAT® STERILE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-04-09
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2022-12-19
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-12-13
MLY Vapocoolant Device Unknown Class U N/A 2024-04-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-12-13
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2012-12-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2022-12-19
MQG Accessory, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6120 2022-03-16
CAK Microfilter, Blood Transfusion General Hospital Class 2 880.5440 2013-02-18
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2024-01-19
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2020-12-31
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2020-12-31
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2024-01-19
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2022-12-19
CAK Microfilter, Blood Transfusion General Hospital Class 2 880.5440 2022-02-01
HDR Cap, Cervical Obstetrics/Gynecology Class 2 884.5250 2024-01-19

Official Correspondent

Alexandra Basset

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

EPIONE BIDCO
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010191069 IONISOS Tarancon Cuenca, ES
3003617485 Ionisos Baltics OU Saue vald Harjumaa, EE
3010329663 IONISOS Pouzauges Pouzauges Vendee, FR
3002807295 IONISOS SABLE-SUR-SARTHE, FR
3010178296 IONISOS Dagneux Ain, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K052493 Steiner Laboratories SOCKET GRAFT 2006-06-09
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003775072. Last updated year: 2026. Please use registration number 3003775072 when referencing this establishment in official correspondence.
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