Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008824097

FEI Number

3008824097

Entity Name

STERIS Sterilization Technologies (Suzhou) Ltd

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No26 Xinchang Road, Suzhou Industrial Park, Suzhou Jiangsu CP215125, CN

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

Insulet5490 (SZ,VL2) - Omnipod DASH Insulin Management System Insulet5490 (SZ) - OmniPod Insulin Management System Covidien34498 (SZ) - Valleylab Suction Coagulator Insulet5490 (SZ) - PodPals Adhesive Overlay Bedal12006 (ED,VL2) - Bedal Flex XS, Bedal Flex S, Bedal Flex M Wallaby (SZ) - Esperance 3+ Aspiration Catheter System Wallaby (SZ) - Esperance Aspiration Catheter System Covidien34498 (SZ) - Valleylab Suction Coagulator Wallaby (SZ) - Wallaby Avenir Coil System Wallaby (SZ) - Pilote Long Sheath Insulet5490 (SZ) - Omnipod 5 Automated Insulin Delivery System Covidien34498 (SZ) - Valleylab Suction Coagulator Insulet5490 (SZ) - Omnipod GO Insulin Delivery Device FirstWater14138 (RG) - F12LB/648/C1/2 Dr Scholl's Blister Cushion Dressing FirstWater14138 (RG) - F10LB/599/G2/2 Dr Scholls Corn Cushion - New Liner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2013-01-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-01-21
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2019-03-11
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2024-09-10
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2024-09-10
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-09-10
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2024-11-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-03-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-03-17
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2019-03-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-09-20
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-11-14
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2013-01-21
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-03-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-01-16
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-09-19
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2023-08-23
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2014-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-09-20
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2025-02-20
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-08-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-08-23
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-08-23
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2024-09-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-03-17
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2025-03-17
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2019-03-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-03-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-09-20
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-12-20
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2019-03-10
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2024-09-10
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2019-03-11
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2019-02-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-03-17
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2025-03-17

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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0005-2013	Animas Corporation	2	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Z-0010-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 712
Z-0011-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 512
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.

Similar Registrations

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1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
2022435	Sterigenics U.S., LLC	Tustin, CA, US
2648727	CUSTOMED, INC.	Fajardo, PR, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008824097. Last updated year: 2026. Please use registration number 3008824097 when referencing this establishment in official correspondence.