Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021393555

FEI Number

3021393555

Entity Name

INCELER MEDIKAL SAGLIK HIZ. SAN. LTD. STI.

City/State/Country

ankara, TR

Establishment Address

IVEDIK ORGANIZE SAN. BOL. (OSB), MAH. 1472. CAD. NO: 120, ankara 06378, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INCELER MEDIKAL SAGLIK HIZ. SAN. LTD. STI. (Owner Number: 10083980)

Owner / Operator Contact Address

IVEDIK ORGANIZE SAN. BOL. (OSB), MAH. 1472. CAD. NO: 120, ankara, TR-06 06378, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Modus Aquapress Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-01-05
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2026-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

INCELER MEDIKAL SAGLIK HIZ. SAN. LTD. STI.

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 3021393555. Last updated year: 2026. Please use registration number 3021393555 when referencing this establishment in official correspondence.