Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017059795

FEI Number

3017059795

Entity Name

Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.

City/State/Country

Tekirdag, TR

Establishment Address

Velimese Osb. Mah. 242 Sok. Subiomedikal Blok No:9/2 Ergene, Tekirdag 59930, TR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A.S. (Owner Number: 10074958)

Owner / Operator Contact Address

Velimese Osb. Mah. 242 Sok. Subiomedikal Blok No:9/2 Ergene, Tekirdag, TR-59 59930, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dialysis Set, Catheter Set EASY HD Dialysis Set, EASY HD Fistula Kit, EASY HD Catheter Set, EASY HD Catheter Kit SUBMED Brand Microscope Cover SUBMED Plain Drape, Surgical Drapes, Microscope Cover, CVC Drape, Catheter Drape, Fenestrated Drape, Adhesive Drape SUBMED Urethral Catheter Set SubMed SubMed EASY HD Catheter Pouch, SUBMED Catheter Shower Pouch SUBMED Laceration Treatment Kit SUBMED CVC Kit SUBMED I.V. Start Kit SUBMED Non-woven/Gauze Swab, Non-woven/Gauze Ball,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2023-09-13
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-03-01
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	Class 2	876.5130	2026-06-09
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-03
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-07-17
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2024-09-30
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-06-09
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	Class 2	880.5200	2024-09-30
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2026-06-09
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-09-30

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Matorin Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve 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 3017059795. Last updated year: 2026. Please use registration number 3017059795 when referencing this establishment in official correspondence.