FDA Registration
Active
🇳🇱 Netherlands
Synergy Health Ede BV
Reg #: 3009337401
·
FEI: 3009337401
·
Expires 2026
Products
49
Proprietary Names
74
Establishment Types
1
Classifications
49
Registration Details
- Registration Name
- Synergy Health Ede BV
- Registration Number
- 3009337401
- FEI Number
- 3009337401
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Faunalaan38
- City
- Venlo Limburg
- Country
- NL
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2020-12-08 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2025-12-01 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2020-01-29 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2024-02-20 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Surgical Film | OOD | Class 2 | General, Plastic Surgery | No | 2022-10-26 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2022-10-26 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2022-10-26 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2021-02-22 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2021-02-22 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2023-12-08 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2020-01-29 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2020-01-29 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2020-01-29 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2016-12-19 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2013-03-20 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2024-06-25 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2019-09-04 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2025-08-27 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2013-03-18 |
| Aid, Surgical, Viscoelastic | LZP | Class 3 | Ophthalmic | No | 2021-02-15 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2021-02-15 |
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2020-01-28 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2025-12-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-02-26 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2020-03-11 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2018-12-27 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2013-03-19 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-01-24 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2019-12-23 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2019-12-23 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2013-03-18 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2024-02-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-02-23 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2013-03-18 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2025-08-27 |
| Photokeratoscope | HJA | Class 1 | Ophthalmic | No | 2020-01-29 |
| Obstetrical Kit | OKV | Class 2 | Obstetrics/Gynecology | No | 2020-11-30 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2020-01-29 |
| Implant, Orbital, Extra-Ocular | HQX | Class 2 | Ophthalmic | No | 2021-01-26 |
| Aspirator, Endometrial | HFF | Class 2 | Obstetrics/Gynecology | No | 2013-03-18 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2013-03-18 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2013-01-22 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2020-01-29 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2017-01-16 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2012-12-20 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-01-22 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-10-19 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2013-03-18 |
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,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
Rover35148 (VL) - Rovers EndoCervex-Brush-S
Rover35148 (VL) - Rovers® EndoCervex-Brush® RT
Rover35148 (VL) - Rovers EndoCervex-Brush
Rover35148 (VL) - Rovers® EndoCervex-Brush®-S RT
DORC10527 (VL1) - Lens, Contact, Polymethylmethacrylate, Diagnostic
DORC10527 (VL1) - MicroVision Scleral Buckling Components
BVI8325 (RG) - LASIK CANNULA (DAYA)
D.O.R.C. (VL1) - Backflush instrument
DORC10527 (VL1) - Cannula, Ophthalmic
Jabil8683 (DK) - CONFIDENCE Spinal Cement System
DORC10527 (VL1) - Cannula, Trocar, Ophthalmic
Novartis14265 (VL1) - DiscoVisc
Novartis14265 (VL1) - Duovisc
Novartis14265 (VL1) - Viscoat
DORC10527 (VL1) - Phacoemulsification / Vitrectomy System / Ophthalmic Laser
DORC10527 (VL1) - Scissors, Ophthalmic
BlinkMedical8355 (TH) - Surgical Forceps
Molnlycke (VL,KK) - Biogel PI Micro surgical glove
Molnlycke (KK,VL) - Biogel PI Pro-Fit surgical glove; Biogel PI Ultratouch G surgical glove; Biogel PI UltraTouch M
Molnlycke (KK,VL) - Biogel PI UltraTouch surgical glove
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)