Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010191069

FEI Number

3010191069

Entity Name

IONISOS

City/State/Country

Tarancon Cuenca, ES

Establishment Address

Poligono Industrial "Tarancon Sur", C/ Rocinante parcela 50, Tarancon Cuenca 16400, ES

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STERN FIX - Neos Surgery S.L. STERN FIX Sternal Stabilization System - Neos Surgery S.L. Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System - Neos Surgery S.L.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2024-01-22
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2024-01-22
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2024-01-22

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
3003617485	Ionisos Baltics OU	Saue vald Harjumaa, EE
3003775072	IONISOS	CHAUMESNIL Grand Est, FR
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
K874919	Orthomet, Inc.	ORTHOMET WIRE FOR SUTURE, CERCLAGE	1988-01-07

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1825034	BIOMET, INC.	WARSAW, IN, US
3015207155	Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010191069. Last updated year: 2026. Please use registration number 3010191069 when referencing this establishment in official correspondence.