Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018940271

FEI Number

3018940271

Entity Name

BIOPARK MEDIKAL SANAYI VE TICARET ANONIM SIRKETI

City/State/Country

Istanbul, TR

Establishment Address

Halkali Merkez Mah. Fatih Cad. Sima Is Merkezi No:18/10 Kucukcekmece, Istanbul 34303, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOPARK MEDIKAL SANAYI VE TICARET ANONIM SIRKETI (Owner Number: 10081688)

Owner / Operator Contact Address

Halkali Merkez Mah. Fatih Cad. Sima Is Merkezi No:18/10 Kucukcekmece, Istanbul, TR-34 34303, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

M&PGun

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2021-05-07

Official Correspondent

Emine Hasret GUL

US Agent Details

Mete Hakan Karalok Email: hakan.karalok.ny@gmail.com Phone: (203) 5844310

Related Public Records

Same Entity

BIOPARK MEDIKAL SANAYI VE TICARET ANONIM 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
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01

Similar Registrations

Registration Number	Establishment Name	Location
3034246209	Baz Biomedic Co., Ltd.	Seoul, KR
3012447612	Highridge Medical, LLC	Westminster, CO, US
1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
3013493300	Devroye Instruments SRL	Etterbeek Brussels-Capital Region, BE
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018940271. Last updated year: 2026. Please use registration number 3018940271 when referencing this establishment in official correspondence.