FDA Registration
Active
🇮🇱 Israel
Euroband Bioline LTD.
Reg #: 9611024
·
FEI: 3002807170
·
Expires 2026
Products
44
Proprietary Names
54
Establishment Types
2
Classifications
43
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Registration Details
- Registration Name
- Euroband Bioline LTD.
- Registration Number
- 9611024
- FEI Number
- 3002807170
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 31 GESHER HAETZ ST., INDUSTRIAL PARK EMEK HEFER
- City
- INDUSTRIAL PARK EMEK HEFER Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K801991
Owner / Operator
- Firm Name
- Euroband Bioline Ltd
- Operator Number
- 10047611
- Address
- GESHER HAETZ 31 ST., INDUSTRIAL PARK EMEK HEFER
- City
- INDUSTRIAL PARK EMEK HEFER
- State
- Central
- Postal Code
- 3877701
- Country
- IL
- Correspondent
- Noa Weber
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Plastic Surgery And Accessories Kit | FTN | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2014-12-08 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2014-10-14 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Tube, Levine | FRQ | Class 2 | Gastroenterology, Urology | No | 2014-10-14 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2014-10-14 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2014-10-14 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2014-10-12 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2014-10-12 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2014-10-14 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2014-10-12 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2014-10-14 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2014-10-14 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2014-10-12 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2014-12-04 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2014-12-04 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2014-10-12 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2014-10-14 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2014-10-12 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2014-10-12 |
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | Class 2 | Gastroenterology, Urology | No | 2014-10-14 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2014-10-14 |
| LDQ | No | 2014-10-14 | |||
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2014-10-14 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2014-10-14 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2014-10-14 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Brush, Cleaning, Tracheal Tube | EPE | Class 1 | Anesthesiology | No | 2014-10-14 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2014-10-14 |
| Tray, Start/Stop (Including Contents), Dialysis | FKG | Class 1 | Gastroenterology, Urology | No | 2014-10-14 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2014-10-14 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2014-10-14 |
| Probe | HXB | Class 1 | Orthopedic | No | 2014-10-14 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2014-10-14 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2014-10-14 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2014-10-14 |
| Clamp, Line | FKK | Class 1 | Gastroenterology, Urology | No | 2014-10-12 |
Proprietary Names
Surgical instruments procedural tray
Urinary kit for drainage collection
PLASTIC FORCEPS CAT.#1001-1010
X-Ray detectable gauze
Syringe
SilvalGuard
Non absorbent sponge
Pediwet - Paraffin Gauze
Hemostat
Scalpels - Knife Surgical
Needle Holder
Urinal Catheter Procedure Tray
Neuro Surgical Sponges - PETIPAD
Surgical Drape
Container Specimen
Gauze Sponges
Urinal Collection Bag
Syringes, pre-filled, water or air
SilvalSac
Dressing Change Tray
UMBICUT
Eye Applicator
Cotton Tipped Applicator
Cast bandage
PREP SET CAT.#908
Wound dressing
First Aid Bandage
Pedicat
Umbilical Clamp
Needle holder
Staple Remover
ENT nasal splint
Razor Plastic Disposable
Gauze Swabs
Hot/Cold water container
Elastic Bandage
Adhesive tape and bandage
Tracheostomy Fixator
Eye pads
Tracheostomy Brush
Forceps
Suture Removal Tray
Surgical Instruments procedural tray
Hot/Cold pack
Dialysis Dressing Tray
Urinary Procedural Tray
Biopsy Kit
First Aid Kits
Probe
Scalpel
Pre Filled Syringes
General and Plastic Surgery Forceps
Disposable medical Scissors
Flowclamp
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device