Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022177334

FEI Number

3022177334

Entity Name

GLOBAL BIYOMEDIKAL SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI

City/State/Country

Bakirkoy Istanbul, TR

Establishment Address

YESiLKoY MAH. ATATuRK CAD. NO: 12 Ic KAPI NO: 368, Bakirkoy Istanbul 34149, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GLOBAL BIYOMEDIKAL SAGLIK HIZMETLERI SANAYI VE TICARET LIMIT (Owner Number: 10085810)

Owner / Operator Contact Address

Yesilkoy Mah. Ataturk Cad. No:12, B/1 Blok, Ic kapi no: 368, Bakirkoy, TR-34 34149, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GCell Device; GCell Kit Large; GCell Kit Small; GCell Kit Transparent GCell Device GCell Device; GCell Kit Large; GCell Kit Small; GCell Kit Transparent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2022-08-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-08-12
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2022-08-12

Official Correspondent

SECGUL INCE

US Agent Details

Seyithan Hokenek Email: seyithan.hokenek@globalbiyomedikal.com Phone: (346) 9464846

Related Public Records

Same Entity

GLOBAL BIYOMEDIKAL SAGLIK HIZMETLERI SANAYI VE TICARET LIMIT

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022177334. Last updated year: 2026. Please use registration number 3022177334 when referencing this establishment in official correspondence.