Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006972752

FEI Number

3006972752

Entity Name

Stephanix

City/State/Country

La Ricamarie Auvergne-Rhone-Alpes, FR

Establishment Address

10 Rue Jean Moulin, La Ricamarie Auvergne-Rhone-Alpes 42150, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SEDECAL S.A. (Owner Number: 9039772)

Owner / Operator Contact Address

PELAYA, 9 POL., POL. IND. "RIO DE JANEIRO", ALGETE, ES-M 28110, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221335

PMA Number

N/A

All Registered Proprietary Names

D2RS9090 D2RS D2RS_9090_B1_N D2RS_B1_NV2 D2RS_9090_B1_NV2 D2RS_B1_N D2RS_AT_PA_NV2 D2RS9090 D2RS D2RS_9090_AT_PA_NV2 D2RS_9090_AT_PA D2RS_AT_PA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2021-12-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-12-24
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-12-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-06-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-06-19
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2022-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Devan Moser Business: Sedecal USA Inc. Email: DMOSER@SEDECALUSA.COM Phone: (847) 3946960

Related Public Records

Same Entity

SEDECAL S.A.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011347852	A.T.S. Applicazione Tecnologie Speciali s.r.l.	Torre de Roveri Bergamo, IT
3009868110	Metaltronica Spa	Pomezia Roma, IT
9617251	SEDECAL S.A.	ALGETE Madrid (Province), ES

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006972752. Last updated year: 2026. Please use registration number 3006972752 when referencing this establishment in official correspondence.