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
Phone
302 6089028

Products

Device Name Product Code
Tray, Surgical, Instrument FSM
Plastic Surgery And Accessories Kit FTN
Forceps, General & Plastic Surgery GEN
Gauze/Sponge, Internal, X-Ray Detectable GDY
Syringe, Piston FMF
Dressing, Wound, Occlusive NAD
Gauze / Sponge,Nonresorbable For External Use NAB
Tube, Levine FRQ
Hemostat HRQ
Knife, Surgical EMF
Holder, Needle, Gastroenterologic FHQ
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
Neurosurgical Paddie HBA
Drape, Surgical, Antimicrobial KKX
Container, Specimen, Sterile FMH
Gauze/Sponge, Internal EFQ
Bag, Urine Collection, Leg, For External Use, Sterile FAQ
Unit, Syringe, Air And/Or Water ECB
Kit, Surgical Instrument, Disposable KDD
Scissors, Umbilical HDJ
Clamp, Umbilical HFW
Applicator, Absorbent Tipped, Non-Sterile KXF
Bandage, Cast ITG
Tape And Bandage, Adhesive KGX
Lubricant, Patient KMJ
Collector, Urine, Pediatric, For Indwelling Catheter FFH
Staple, Removable (Skin) GDT
Splint, Intranasal Septal LYA
LDQ
Bottle, Hot/Cold Water FPF
Bandage, Elastic FQM
Device, Fixation, Tracheal Tube CBH
Pad, Eye HMP
Brush, Cleaning, Tracheal Tube EPE
Forceps HTD
Pack, Hot Or Cold, Reusable IME
Tray, Start/Stop (Including Contents), Dialysis FKG
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
General Surgery Tray LRO
Probe HXB
Scalpel, One-Piece GDX
Catheter, Urological KOD
Scissors, Medical, Disposable JOK
Clamp, Line FKK

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