Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035387168

FEI Number

3035387168

Entity Name

YENI BIYOTEKNOLOJI ANONIM SIRKETI

City/State/Country

BALCOVA Izmir, TR

Establishment Address

MORFOLOJI D:Z, NO:56-20 INCIRALTI MAHALLESI MITHATPASA CADDESI, BALCOVA Izmir 35330, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

YENI BIYOTEKNOLOJI ANONIM SIRKETI (Owner Number: 10092522)

Owner / Operator Contact Address

MORFOLOJI D:Z, NO:56-20 INCIRALTI MAHALLESI MITHATPASA CADDESI, BALCOVA, TR-35 35330, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FLUSHMAX HEPES buffered cell culture Medium for use in ART KIT 1 IVFMAX Bicarbonate buffered cell culture medium for fertilization by IVF or ICSI mHTFMAX HEPES buffered cell culture Medium for use in ART KIT 1 OILMAX High purity mineral oil SpermCell Smartphone Applied Sperm Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2025-01-16
LQM	Gram Negative Identification Panel	Microbiology	Class 1	866.2660	2025-01-16
DGB	Seminal Fluid, Antigen, Antiserum, Control	Immunology	Class 1	866.5800	2025-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

YENI BIYOTEKNOLOJI 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
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12
K861867	Hazleton Research Products, Inc.	MEM ALPHA EAGLE MEDIUM	1986-05-29
K821916	Dutchland Laboratories, Inc.	IMPROVED MEM-RICHTER'S POWDER MODIF.	1982-07-27
K810767	Dutchland Laboratories, Inc.	RPMI 1640 MEDIUM	1981-05-08

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3005182157	HIMEDIA LABORATORIES PRIVATE LIMITED	DOMBIVLI, THANE Maharashtra, IN
3008496303	REGEN LAB Sa	LE MONT-SUR-LAUSANNE Vaud, CH
1226230	Vericel Corporation	CAMBRIDGE, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035387168. Last updated year: 2026. Please use registration number 3035387168 when referencing this establishment in official correspondence.