FDA Registration
Active
🇳🇱 Netherlands
Synergy Health Ede BV
Reg #: 3020976354
·
FEI: 3020976354
·
Expires 2026
Products
16
Proprietary Names
14
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- Synergy Health Ede BV
- Registration Number
- 3020976354
- FEI Number
- 3020976354
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Faunalaan 46
- 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
- STERIS
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | NJL | Class 3 | Unknown | No | 2013-01-14 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2024-06-06 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2021-02-22 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-04-06 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2022-10-26 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-01-16 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-01-24 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2023-12-18 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2013-12-10 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2024-09-10 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2024-09-10 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2024-09-10 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2026-03-30 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2023-09-06 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
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
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)