FDA Registration
Active
🇳🇱 Netherlands
Synergy Health Ede BV
Reg #: 3009756327
·
FEI: 3002807038
·
Expires 2026
Products
54
Proprietary Names
49
Establishment Types
1
Classifications
54
Registration Details
- Registration Name
- Synergy Health Ede BV
- Registration Number
- 3009756327
- FEI Number
- 3002807038
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Morsestraat 3
- City
- Ede Gelderland
- 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 |
|---|---|---|---|---|---|
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2013-03-18 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2013-01-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-02-06 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-12-15 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-07-29 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2018-12-21 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2026-02-06 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-01-16 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2026-04-24 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2013-01-17 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2022-02-10 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2026-04-08 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2023-12-15 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-12-15 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-11-24 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2017-03-23 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2022-02-10 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2022-02-10 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2022-04-26 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2022-04-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-15 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2023-12-18 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2017-03-23 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-02-06 |
| Agent, Bulking, Injectable For Gastro-Urology Use | LNM | Class 3 | Unknown | No | 2025-04-10 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2026-04-08 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-10-21 |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2013-01-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2026-02-06 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2022-10-26 |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2022-11-06 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2013-03-18 |
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2012-12-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-15 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-03-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-02-26 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2018-12-01 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2014-05-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-10-14 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2024-10-14 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-10-14 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2017-02-27 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2023-08-18 |
| Dish, Tissue Culture | KIZ | Class 1 | Hematology | No | 2013-03-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-03-14 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2022-12-19 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2019-04-30 |
| Implant, Eye Valve | KYF | Class 2 | Ophthalmic | No | 2014-01-13 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2026-02-06 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2013-03-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-16 |
| Air Filter Portable Apparatus | ORC | Class 2 | General, Plastic Surgery | No | 2019-01-25 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2024-01-04 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2017-01-16 |
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
Kuros12218 (ED) - MagnetOs Easypack Putty
Lisi34951 (ED) - Femoral Head
Kuros12218 (ED) - MagnetOs MIS
IMDS (ED) - Guidion
FKG8620 (DK) - FKG
Toul (ED) - LAF -02
Toul (ED) - LAF-02-D
BirrBio12027 (ED,RB) - ART Labware
Natus10057 (ED) - TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)