Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611024

FEI Number

3002807170

Entity Name

Euroband Bioline LTD.

City/State/Country

INDUSTRIAL PARK EMEK HEFER Central, IL

Establishment Address

31 GESHER HAETZ ST., INDUSTRIAL PARK EMEK HEFER, INDUSTRIAL PARK EMEK HEFER Central 3877701, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Euroband Bioline Ltd (Owner Number: 10047611)

Owner / Operator Contact Address

GESHER HAETZ 31 ST., INDUSTRIAL PARK EMEK HEFER, INDUSTRIAL PARK EMEK HEFER, IL-M 3877701, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K892389

PMA Number

N/A

All Registered 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 Syringe 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-10-14
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2014-10-14
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-12-08
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2014-10-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-10-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2014-10-14
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-10-14
FRQ	Tube, Levine	Gastroenterology, Urology	Class 2	876.5980	2014-10-14
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2014-10-14
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-10-14
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2014-10-14
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-10-14
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2014-10-12
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-10-12
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2014-10-14
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2014-10-12
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-10-14
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2014-10-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-10-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2014-10-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-10-12
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2014-12-04
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2014-12-04
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2014-10-12
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2014-10-14
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2014-12-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-10-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-10-12
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2014-10-12
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2014-10-14
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2014-10-14
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2014-10-14
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2014-10-14
LDQ	N/A	N/A	Class N/A	N/A	2014-10-14
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2014-10-14
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2014-10-14
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2014-10-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-10-14
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2014-10-14
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2014-10-14
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2014-10-14
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-10-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-10-12
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2014-10-14
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2014-10-14
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2014-10-14
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2014-10-14

Official Correspondent

Noa Weber

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: Regrek.Cs@Hotmail.Com Phone: (302) 6089028

Related Public Records

Same Entity

Euroband Bioline Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611024. Last updated year: 2026. Please use registration number 9611024 when referencing this establishment in official correspondence.