Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020976354

FEI Number

3020976354

Entity Name

Synergy Health Ede BV

City/State/Country

Venlo Limburg, NL

Establishment Address

Faunalaan 46, Venlo Limburg 5928 RZ, NL

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) - PodPals Adhesive Overlay Bedal12006 (ED,VL2) - Bedal Flex XS, Bedal Flex S, Bedal Flex M 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 Bedal12006 (ED,VL2) - Air S,M; Flex XS, Flex S, Bedal Flex M; Bedal PICC/CVC, PIVC, FlexGrip PICC, FlexGRIP Jr PIVC Bedal12006 (ED,VL2) - FlexGRIP Neo Alpha; FlexGRIP Neo First; FlexGRIP Neo PIVC Bedal12006 (ED,VL2) - NEX- Universal-CVC; 1 Drainpatch; 3 PIVC; 4 EPI/PNB, FlexGrip EPI/PNB; 5 Universal Bedal12006 (ED,VL2) -FlexGrip Universal; FlexGRIP Alpha, FlexGRIP Foley- Universal; FlexGrip CVC; FlexGRIP Jr. PICC 2.7 Ambu10292 (KK) - aScope BronchoSampler 60 SC Klinika34754 (VL2) - Container, Specimen, Sterile Insulet5490 (SZ,VL2) - Omnipod DASH Insulin Management System Insulet5490 (SZ) - OmniPod Insulin Management System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2013-01-14
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-06-06
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2021-02-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-06
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2022-10-26
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-11-25
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-01-16
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2013-01-24
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2023-12-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-06
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-12-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-09-06
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

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020976354. Last updated year: 2026. Please use registration number 3020976354 when referencing this establishment in official correspondence.