Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009337401

FEI Number

3009337401

Entity Name

Synergy Health Ede BV

City/State/Country

Venlo Limburg, NL

Establishment Address

Faunalaan38, Venlo Limburg 5928RZ, 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

DORC10527 (VL1) - Device, Irrigation, Ocular Surgery Perfuze (VL) - Millipede 088 Access Catheter Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive Molnlycke (VL,KK) - Biogel PI Micro Indicator Underglove Molnlycke (KK,VL) - Biogel PI surgical glove D.O.R.C. (VL1) - EVA Ophthalmic surgical system DORC10527 (VL1) - Clip, Iris retractor Insulet5490 (VL) - OmniPod Insulin Management System Rover35148 (VL) - Rovers Viba-Brush Rover35148 (VL) - Rovers Viba-Brush RT Novartis14265 (VL1) - Provisc Molnlycke (KK,VL) - Biogel PI surgical glove Molnlycke (KK,VL1) - Biogel NeoDerm; Biogel Skinsense N Molnlycke (VL,KK) - Biogel PI Orthopro DORC10527 (VL1) - Endoilluminator Molnlycke (KK,VL) - BIOGEL M Molnlycke (KK,VL) - Biogel Eclipse Molnlycke (VL,KK) - Biogel Skinsense DORC10527 (VL1) - Forceps, Ophthalmic DORC10527 (VL1) - Unit, Phacofragmentation Colplast1941 (RB) - SpeediCath Standard Male Colplast1941 (VL1) - SpeediCath Accessories 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 Molnlycke (KK,VL1) - Biogel Indicator Underglove Colplast1941 (VL1) - EasiCath Set Rover35148 (VL) - Rovers® Cervex-Brush® Combi RT Rover35148 (VL) - Rovers Cervex-Brush Combi BlinkMedical8355 (TH) - Surgical Manipulation Instruments DORC10527 (VL1) - Spatula, Ophthalmic Perfuze (VL) - Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Teleflex (TL) - Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Newclip11561 (MS) - Radius instrumentation set; Ulnar Instrumentation set Newclip11561 (MS) - ACTIV Ankle instrumentation set; ACTIV HTO instrumentation set; Activ instrumentation set Base; Acti DORC10527 (VL1) - Tray, Surgical, Instrument Newclip11561 (MS) - Stainless steel - Cover; HammerToe instrumentation set - Base; HammerToe instrumentation set Newclip11561 (MS) - Clavicle Distal instrumentation set; Elbow instrumentation set; Foot and Hand Motion Newclip11561 (MS) - Footmotion instrumentation set; Footmotion Plating System MTP instrumentation set; HammerToe Newclip11561 (MS) - Screws tray; Activ instrumentation set Top Alians Elbow Distal Humerus Y Plates instrumentation set Newclip11561 (MS) - HammerToe instrumentation set Stainless steel - Base; Humerus instrumentation set; Large screw Molnlycke (KK,VL1) - Biogel Sensor Glove; Biogel Super-Sensitive surgical glove Alcon8548 (DK) - GRIESHABER ULTRASHARP Knife (Sclerotomy, Discission or Scleral Pocket) Rover35148 (VL) - Rovers® Cervex-Brush® RT Rover35148 (VL) - Rovers Cervex-Brush Rover35148 (VL) - Rovers Orcellex Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2020-12-08
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2025-12-01
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2020-01-29
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-02-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-12-20
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2022-10-26
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	General, Plastic Surgery	Class 2	878.3300	2022-10-26
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-10-26
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2021-02-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2021-02-22
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2021-02-22
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2020-01-29
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2020-01-29
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2020-01-29
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2016-12-19
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2013-03-20
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2024-06-25
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2019-09-04
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2025-08-27
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-03-18
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2021-02-15
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2021-02-15
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2020-01-28
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2025-07-02
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-08
OJG	Neurological Tray	Neurology	Class 1	882.4525	2025-12-01
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-02-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-03-11
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-12-27
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-03-18
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-19
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2020-01-28
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2019-12-23
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2013-01-24
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2019-12-23
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2019-12-23
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2025-08-27
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-02-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-02-23
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-18
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2025-08-27
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-12-19
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2021-02-22
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-08-27

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
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0490-2025	Alcon Research LLC	2	a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
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-0306-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009337401. Last updated year: 2026. Please use registration number 3009337401 when referencing this establishment in official correspondence.