Synergy Health Sterilisation UK Ltd

FDA Device Registration & Listing · Swindon Wiltshire, GB · Registration 3010132111

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
3010132111
FEI Number
3010132111
Entity Name
Synergy Health Sterilisation UK Ltd
City/State/Country
Swindon Wiltshire, GB
Establishment Address
Moray Road, Elgin Industrial Estate, Swindon Wiltshire SN2 8XS, GB
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

Rover35148 (VL) - Rovers Anex Brush SteripackPoland (RB,DK,VL2,) - Sterile Flocked Swab; Sterile Foam Swab; SteriPack Sterile Polyester Spun Swab and Swab SteriPack9541 (RB,DK,VL2) - Sterile Polyester Spun Swab Rover35148 (VL) - Rovers Evalyn Brush FirstWater14138 (RG) - 79933-03 - Cutimed Sorbact Hydroactive Border ST FirstWater14138 (RG) - 79933-04 - Cutimed Sorbact Hydroactive Border ST FirstWater14138 (RG) - 72646-05 - Cutimed Sorbact Hydroactive ST FirstWater14138 (RG) - 79933-00 - Cutimed Sorbact FirstWater14138 (RG) - 72646-03 - Cutimed Sorbact Hydroactive ST FirstWater14138 (RG) - 72646-07 - Cutimed Sorbact Hydroactive ST FirstWater14138 (RG) - 72646-04 - Cutimed Sorbact Hydroactive ST FirstWater14138 (RG) - 72646-06 - Cutimed Sorbact Hydroactive ST FirstWater14138 (RG) - 79933-02 - Cutimed Sorbact Hydroactive Border ST FirstWater14138 (RG,SE) - Medela Breast Pads (USA) FirstWater14138 (RG) - 73230-02 - Leukomed Control Sterile FirstWater14138 (RG) - 73230-03 - Leukomed Control Sterile FirstWater14138 (RG) - DUP86466-9 - Xtrasorb HCS Adhesive FirstWater14138 (RG) - Russell Chest Seal FirstWater14138 (RG) - DUP86322-9 Xtrasorb HCS FirstWater14138 (RG) - 73230-05 - Leukomed Control Sterile FirstWater14138 (RG) - CWL 1008 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1005 - KerraLite Cool FirstWater14138 (RG) - Curad “Soothe & Cool” Dressing (56 x 26mm) FirstWater14138 (RG) - CWL 1009 - KerraLite Cool Border FirstWater14138 (RG) - 6030-4156 - Glaciergel FirstWater14138 (RG) - CWL 1004 - KerraLite Cool FirstWater14138 (RG) - 73230-00 - Leukomed Control Sterile FirstWater14138 (RG) - CVS86433-9 Xtrasorb HCS Non- Adhesive 3""x3"" (cvs) FirstWater14138 (RG) - 40-2979 - Hydrogel Dressing FirstWater14138 (RG) - DUP86344 - Xtrasorb HCS 4.5" X 4.5" FirstWater14138 (RG) - DUP86388-9 - Xtrasorb HCS Non- Adhesive FirstWater14138 (RG) - 6030-4157 - Glaciergel FirstWater14138 (RG) - 73230-01 - Leukomed Control Sterile FirstWater14138 (RG) - Curad “Soothe & Cool” Dressing (74 x 45mm) FirstWater14138 (RG) - CWL 1007 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1006 - KerraLite Cool

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2020-12-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-09-14
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2013-01-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-01-02
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-01-21
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2022-11-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2013-05-03
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-01-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2013-03-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-10
HRX Arthroscope Orthopedic Class 2 888.1100 2013-01-10
KCW Epilator, High Frequency, Needle-Type General, Plastic Surgery Class 1 878.5350 2013-03-22
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-09-14
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-09-14
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-09-14
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-09-14
NTC Nursing Pad, Hydrogel General Hospital Class 1 880.5630 2013-03-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-10-20
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-12-19
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2013-01-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-01-14
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-01-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-10-20
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2020-01-28
JXB Kit, Identification, Yeast Microbiology Class 1 866.2660 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
HRX Arthroscope Orthopedic Class 2 888.1100 2013-05-03
NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown Class 3 N/A 2013-01-14
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2012-12-20
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-21
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-21
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2015-04-07
LOD Bone Cement Orthopedic Class 2 888.3027 2015-04-07
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-09-14
KMF Bandage, Liquid General Hospital Class 1 880.5090 2016-01-12
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-12-19
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2015-07-22
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2013-03-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-05-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-10-20
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-09-14
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-09-14
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS Corporation 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
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K901338 Kirschner Medical Corp. KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM 1990-05-22
K030577 Stelkast Company PROVEN MODULAR TIBIAL TRAY 2003-03-25
K153310 Total Joint Orthopedics, Inc. Klassic Knee System 2015-12-17
K102380 Wrightmedicaltechnologyinc EVOLUTION MP TOTAL KNEE SYSTEM 2011-01-07
K122985 Aesculap Implant System, Inc. COLUMBUS REVISION KNEE SYSTEM 2012-10-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019 Smith & Nephew, Inc. 2
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017 Zimmer Biomet, Inc. 2
Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019 Smith & Nephew, Inc. 2
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06 Plus Orthopedics USA 2
TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010132111. Last updated year: 2026. Please use registration number 3010132111 when referencing this establishment in official correspondence.
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