Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008045828

FEI Number

3008045828

Entity Name

Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti

City/State/Country

Izmir, TR

Establishment Address

Zafer SB MAh Gunduz Sk No:13 Ege Serbest Bolge Gaziemir IZmir, Izmir 35620, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Lansinoh Laboratories Saglik Ger. Tas. San. Tic. Ltd. Sti. (Owner Number: 10030867)

Owner / Operator Contact Address

Zafer SB Mah. Gunduz Sk. No:13, Gaziemir, Izmir, TR-35 35035, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122474

PMA Number

N/A

All Registered Proprietary Names

Affinity Double Electr Breast Pump Smartpump 3 Double Electric Breast Pump NaturalWave Double Electric Breast Pump Compact Wearable Pump Signature Comfort Double Electric Breast Pump Signature Pro Double Electric Breast Pump Smartpump 2 Double Electric Breast Pump Soothies C-section Recovery Pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2009-11-24
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-03-20
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-07-03
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2019-12-11
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2022-08-02
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2013-11-22

Official Correspondent

Barbaros Karadag

US Agent Details

Jeff VanderHoek Business: Lansinoh Laboratories Ins. Email: jvanderhoek@lansinoh.com Phone: (760) 2015607

Related Public Records

Same Entity

Lansinoh Laboratories Saglik Ger. Tas. San. Tic. Ltd. Sti.

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
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008045828. Last updated year: 2026. Please use registration number 3008045828 when referencing this establishment in official correspondence.