Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013561139

FEI Number

3013561139

Entity Name

CIMILRE CO., LTD.

City/State/Country

Cheonan-si Chungnam, KR

Establishment Address

97-14, Seongnam-ro, Mokcheon-eup,, Dongnam-gu, Cheonan-si Chungnam 31234, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CIMILRE CO.,LTD (Owner Number: 10054474)

Owner / Operator Contact Address

97-14, Seongnam-ro, Mokcheon-eup,, Dongnam-gu, Cheonan-si, KR-44 31234, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AMEDA MYA PRO HYGEIA FIT Motif Luna with Battery CIMILRE S3 MOTIF MEDICAL LUNA CIMILRE F1 CIMILRE S6 AMEDA MYA CIMILRE P1 CIMILRE S6 plus 28mm Double Pumping Kit 24mm Double Pumping Kit

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	2022-12-25
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2017-03-22
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2019-05-18
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2019-05-20

Official Correspondent

Misun Na

US Agent Details

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

Related Public Records

Same Entity

CIMILRE CO.,LTD

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 3013561139. Last updated year: 2026. Please use registration number 3013561139 when referencing this establishment in official correspondence.