FDA Registration
Active
🇫🇷 France
IONISOS
Reg #: 3003775072
·
FEI: 3003775072
·
Expires 2026
Products
15
Proprietary Names
49
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- IONISOS
- Registration Number
- 3003775072
- FEI Number
- 3003775072
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZI
- City
- CHAUMESNIL Grand Est
- Country
- FR
Owner / Operator
- Firm Name
- EPIONE BIDCO
- Operator Number
- 10042490
- Address
- 415 allee de Frenes, bat Squale
- City
- LIMONEST
- State
- Rhone
- Postal Code
- 69760
- Country
- FR
- Correspondent
- Alexandra Basset
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 Nw 12th St Ste 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-04-09 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2022-12-19 |
| Vapocoolant Device | MLY | Class U | Unknown | No | 2024-04-09 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-12-13 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2022-12-19 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2022-03-16 |
| Microfilter, Blood Transfusion | CAK | Class 2 | General Hospital | No | 2013-02-18 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2024-01-19 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2020-12-31 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2020-12-31 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2024-01-19 |
| Cap, Cervical | HDR | Class 2 | Obstetrics/Gynecology | No | 2024-01-19 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-13 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2022-03-16 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-02-01 |
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
HSV Straw
High-Security Vitrification (HSV) Kit
BIONECTOR -SOFT BLISTER PK 50C
Bionector
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)