Synergy Health Marseille SAS

FDA Device Registration & Listing · CHUSCLAN Gard, FR · Registration 3010897183

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
3010897183
FEI Number
3010897183
Entity Name
Synergy Health Marseille SAS
City/State/Country
CHUSCLAN Gard, FR
Establishment Address
ISOTRON ISOTRON FRANCE SA RD, 138 LIEU DIT COMBE BERTRAND, CHUSCLAN Gard 30200, FR
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 10042227)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Noraker11562 (MS) - ARTHREX QUICKSET; ARTHREX QUICKSET KIT; GRAFTYS QUICKSET; GRAFTYS QUICKSET KIT Union12544 (ED,MC) - UNION PLASTIC DIVISION APE Union12544 (ED,MC) - UNION PLASTIC DIVISION APE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-11-03
DZM Needle, Dental Dental Class 1 872.4730 2015-08-06
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-12-19
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY
3017616393 STERIS TOMOE (Thailand) Ltd. Chonburi Chon Buri, TH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13
K243985 Icu Medical, Inc. Rio™ Drug Reconstitution Transfer Device 2025-01-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2017 Baxter Corporation Englewood 2
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

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3043620406 REVOGEN BIOLOGICS San Antonio, TX, US
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010897183. Last updated year: 2026. Please use registration number 3010897183 when referencing this establishment in official correspondence.
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