Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010155648

FEI Number

3010155648

Entity Name

Synergy Health Sterilisation UK Ltd

City/State/Country

West Yorkshire Bradford, GB

Establishment Address

Roydsdale Way, West Yorkshire Bradford BD4 6SE, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical_Inno3346 (BF) - YelloPort Elite Single Use Seal DepuyOrtho (BF) - COVER, BURR HOLE Surgical_Inno3346 (DV,BF*) - YelloPort Plus Single Use Valves Surgical_Inno3346 (DV,BF*) - Logi Single Use Inserts Surgical_Inno3346 (DV,BF*) - LogiFlex Gastric Band Positioning Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2017-01-26
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2015-05-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2015-05-15
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-09-11
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-02-02
EJL	Bur, Dental	Dental	Class 1	872.3240	2013-12-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-12-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-11-20
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2023-12-19
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2023-12-19
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2013-12-13
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-12-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-13
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-12-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-12-13
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2025-12-04
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2018-09-03
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2018-09-03
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-02-26
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2023-12-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-12-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-03-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-12-03
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2017-06-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-12-19
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-12-24
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-01-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-09-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-09-03
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2020-04-07
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2021-07-15
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2021-07-15
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2017-07-31
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2015-05-15
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2013-01-24
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2013-01-24
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2020-04-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-01-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-03-28
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-09-03
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-04-28
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2018-09-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-03-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-12-16
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-02-02
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-02-18
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-04-23
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)	Neurology	Class 2	882.4305	2013-02-18

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
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
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.

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9616696	STRYKER IRELAND LTD., INSTRUMENTS DIVISION	CARRIGTWOHILL, CO.CORK Munster, IE
1824199	WARSAW ORTHOPEDIC, INC.	WARSAW, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010155648. Last updated year: 2026. Please use registration number 3010155648 when referencing this establishment in official correspondence.