Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009756327

FEI Number

3002807038

Entity Name

Synergy Health Ede BV

City/State/Country

Ede Gelderland, NL

Establishment Address

Morsestraat 3, Ede Gelderland GLD 6716AH, 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 KiroGrifols6932 (ED) - KIRO Set IMDS (ED) - ReCross EMCM12089 (ED) - NervAlign Nerve Cuff Kuros12218 (ED) - MagnetOs Putty IMDS (ED) - TrapIt Newclip11561 (MS) - BIT, DRILL IMDS (ED) - Micro Rx 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 Kuros (ED) - MagnetOs Granules Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins; Lisi34951 (ED) - Exeter Hip System IMDS12182 (ED) - ShapeIT IMDS (ED) - Nhancer Rx Lisi34951 (ED) - Exeter V40, 37.5mm, N1, L. 125mm Lisi34951 (ED) - Orthinox 22.2mm/-2mm V40 Femoral Head Lisi34951 (ED) - Orthinox 22.2mm/+3mm V40 Femoral Head Lisi34951 (ED) - Exeter V40, 37.5mm, N1, L.205 fully tapered Lisi34951 (ED) - Exeter V40, 56mm,N2, L. 150mm Lisi34951 (ED) - Exeter V40, 50mm, N1, L. 125mm Lisi34951 (ED) - Exeter V40, 56mm,N1, L. 150mm Lisi34951 (ED) - Exeter V40, 44mm, N1, L. 125mm Natus10057 (ED) - Dantec DCN Disposable Concentric Needle BirrBio12027 (ED) - ART Dish Lisi34951 (ED) - Dall Miles Trochanteric Grip Plate Lisi34951 (ED) - X-Change Mesh Lisi34951 (ED) - Orthinox V40 Femoral Heads Lisi34951 (ED) - Dall Miles Trochanteric Grip with 2 cables Lisi34951 (ED) - Dall Miles Trochanteric Grip Lisi34951 (ED) - Exeter V40 Femoral Stems Union12544 (ED,MC) - UNION PLASTIC DIVISION APE Union12544 (ED,MC) - UNION PLASTIC DIVISION APE Kuros12218 (ED) - MagnetOs Easypack Putty

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2013-03-18
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2013-01-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-02-06
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-12-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-07-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-07-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-21
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-02-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-01-16
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2026-04-24
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2013-01-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-02-10
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2026-04-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-17
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2023-12-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-12-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-04-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-11-24
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-03-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-02-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-02-10
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2022-04-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-04-26
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2022-04-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-04-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-02-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-11-02
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-02-06
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2023-12-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-12-21
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2018-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-11-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-04-26
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2017-03-23
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-03-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-02-06
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-02-10
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2025-04-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-01-01
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2026-04-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-10-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2013-01-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-02-06
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2022-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-02-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-12-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-11-06
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2022-11-06
QRQ	Non-Irrigation Endosseous Dental Implant Drill Bits	Dental	Class 1	872.3980	2022-11-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-11-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-02-06
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-03-18
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-02-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-12-21
NIM	Stent, Carotid	Unknown	Class 3	N/A	2012-12-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-06-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-06-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-03-23
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-26
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2018-12-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-12-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-03-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-01-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2014-05-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-02-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-02-10
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-03-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-10-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-10-14
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2024-10-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-10-14
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2017-02-27
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2023-08-18
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-12-21
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2013-03-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-03-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-12-19
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2022-12-19
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2018-12-01
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-12-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-11-24
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2018-12-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-04-30
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2014-01-13

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
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

Similar Registrations

Registration Number	Establishment Name	Location
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US
3017896194	Dongguan King Medical Technology Co.,Ltd	Dongguan Guangdong, CN
9617744	Allwin Medical Devices Pvt. Ltd.	Surat Gujarat, IN
3008876063	KITAZATO CORPORATION	Fuji Shizuoka, JP
3005987240	ALLWIN MEDICAL DEVICES, INC.	ANAHEIM, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009756327. Last updated year: 2026. Please use registration number 3009756327 when referencing this establishment in official correspondence.