Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017102771

FEI Number

3017102771

Entity Name

EMMA HEALTHCARE CO., LTD.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

329, 26, Yatap-ro 205beon-gil, Bundang-gu, Seongnam-si Gyeonggi 13503, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Emma Healthcare Co., Ltd. (Owner Number: 10090848)

Owner / Operator Contact Address

329, 26, Yatap-ro 205beon-gil, Bundang-gu, Seongnam-si, KR-41 13503, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Turn Buddy System_EH-TBS-01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QEF	Pressure Ulcer Management Tool	Gastroenterology, Urology	Class 1	876.2100	2024-05-21

Official Correspondent

Ryanghee Sohn

US Agent Details

Susan Carlock Business: MILLER CO MEDICAL DEVICES LLC Email: susan@pivotManufacturing.com Phone: (765) 2822221

Related Public Records

Same Entity

Emma Healthcare Co., Ltd.

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 3017102771. Last updated year: 2026. Please use registration number 3017102771 when referencing this establishment in official correspondence.