Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042034415

FEI Number

3042034415

Entity Name

SCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETI

City/State/Country

Fatih Istanbul, TR

Establishment Address

molla gurani mah turgut ozal cad no 84 karagul ismrkz, kaoi no.222, Fatih Istanbul 34093, TR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

scharf tools ihracat ithalat limited sirketi (Owner Number: 10094076)

Owner / Operator Contact Address

molla gurani mah turgut ozal cad no 84 karagul ismrkz, kaoi no.222, Fatih, TR-34 34093, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF SCHARF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-11-23
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2026-01-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-11-23
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-23
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-23
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-23
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-12-08
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2025-11-23
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-11-23
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2025-11-23
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-11-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-02-04

Official Correspondent

HAMZA GONDAL

US Agent Details

Mansoor Baloch Business: SCHARF USA LLC Email: scharfusllc@gmail.com Phone: (704) 2996898

Related Public Records

Same Entity

scharf tools ihracat ithalat limited sirketi

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

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3007389672	FRANKO SHEHZAD SURGICO PVT LTD.	Sialkot Punjab, PK
3011499367	HAZEL ENTERPRISES	Sialkot Punjab, PK
3022748632	TAURUS Medizintechnik GmbH	Fridingen an der Donau Baden-Wurttemberg, DE
3012267976	SURGIPROS LLC	Palmetto, FL, US
8040179	BASHIR JAMIL & BROTHERS (PVT.), LTD.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042034415. Last updated year: 2026. Please use registration number 3042034415 when referencing this establishment in official correspondence.