Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012620142

FEI Number

3012620142

Entity Name

YILMAZ BIO MEDIKAL

City/State/Country

gaziantep, TR

Establishment Address

Mucahitler mahallesi hasirci samibey cd. no:12/A, gaziantep 27090, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yilmaz Medikal (Owner Number: 10052438)

Owner / Operator Contact Address

mucahitler mahallesi hasirci samibey cd. no:12, gaziantep, TR-27 27090, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORYUM OVEM OVEM ORYUM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2019-08-14
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2019-12-14

Official Correspondent

Mustafa NAZLIER

US Agent Details

habes kaplan Business: PERSONAL Email: habes@yilmazmedikal.com Phone: (646) 5082674

Related Public Records

Same Entity

Yilmaz Medikal

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
K000299	Biomedex, Inc.	DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D	2000-04-28
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

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3015536286	ALLERGY & APPLICATOR DEPOT, LLC	Manorville, NY, US
3011088743	CYDONIA PHARMA SL	valencia, ES
1424263	Isomedix Operations, Inc.	Libertyville, IL, US
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012620142. Last updated year: 2026. Please use registration number 3012620142 when referencing this establishment in official correspondence.