Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005690789

FEI Number

3005690789

Entity Name

DISERA TIBBI MALZEME LOJISTIK SANAYI TIC. A.S.

City/State/Country

Tire Izmir, TR

Establishment Address

Ibni Melek OSB, Mahallesi. Tosbi , 35900, Tire Izmir 35900, TR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Disera Tibbi Malzeme Lojistik Sanayi Tic. A.S. (Owner Number: 10090595)

Owner / Operator Contact Address

Ibni Melek OSB, Mahallesi. Tosbi Yol 5 Sk. NO:46, 35900, Tire, TR-35 35900, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VACUSERA® AUTOMATIC PINKTOURNIQUET FOR CHILDREN VACUSERA® AUTOMATIC GREEN TOURNIQUET FOR CHILDREN VACUSERA® PRF TUBES VACUSERA® SAFETY HOLDER VACUSERA® DISPOSABLE TOURNIQUET VACUSERA® LUER LOCK BLOOD COLLECTION HOLDER-MALE VACUSERA® PRF TUBE VACUSERA® LUER LOCK BLOOD COLLECTION HOLDER-FEMALE VACUSERA® LUER ADAPTER 20 G + STANDARD HOLDER VACUSERA® LUER ADAPTER 20G VACUSERA® BLOOD COLLECTION NEEDLE HOLDER VACUSERA® AUTOMATIC TOURNIQUET 536820 VACUSERA® 10 ml Urine Tube - Chlorhexidine 536810 VACUSERA® 10 ml Urine Tube - Boric Acid 503001 VACUSERA® Urine Beaker Red Cap 535816 VACUSERA® 6 ml Urine Tube - Boric Acid 536828 VACUSERA® 8 ml Urine Tube - Chlorhexidine 503026 VACUSERA® Urine Beaker with Integrated Holder 536800 VACUSERA® 10 ml Urine Tube 535806 VACUSERA® 6 ml Urine Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2025-01-16
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2024-04-17

Official Correspondent

Kenan Deniz BUYUKAKMAN

US Agent Details

David Barka Business: CALBIOTECH, INC. Email: dbarka@calbiotech.com Phone: (619) 7083999

Related Public Records

Same Entity

Disera Tibbi Malzeme Lojistik Sanayi Tic. A.S.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005690789. Last updated year: 2026. Please use registration number 3005690789 when referencing this establishment in official correspondence.