Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044777128

FEI Number

3044777128

Entity Name

EM TECH.INC

City/State/Country

Bucheon-si Gyeonggi, KR

Establishment Address

40-25Seokcheon-ro 531beon-gil,Ojeong-gu, Bucheon-si Gyeonggi 14400, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

EM Tech.Inc (Owner Number: 10095711)

Owner / Operator Contact Address

40-25Seokcheon-ro 531beon-gil,Ojeong-gu, Bucheon-si, KR-41 14400, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EMR-64PN EMR-64PI EMR-25PI EMR-36PI EMR-25PN EMR-49PI EMR-49PN EMR-36PN RF Micro Needle Tip (Model: RMT-N49) RF Micro Needle Tip (Model: RMT-I49) RF Micro Needle Tip (Model: RMT-N25) RF Micro Needle Tip (Model: RMT-I25) RF Micro Needle Tip (Model: RMT-N25) A-FIT RF Needle Tip (Model: A-FIT RN 1.2) RF Micro Needle Tip (Model: RMT-I25) A-FIT RF Needle Tip (Model: A-FIT RN 1.5) RF Micro Needle Tip (Model: RMT-I49) RF Micro Needle Tip (Model: RMT-N49) A-FIT RF Needle Tip (Model: A-FIT RN 1.8)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-04-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-05-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-05-22

Official Correspondent

CHANG HOON LEE

US Agent Details

Mateo Carrasco Email: info@afpharmaservice.com Phone: (407) 2849480

Related Public Records

Same Entity

EM Tech.Inc

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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3029952419	DIAMINY MEDICAL AESTHETICS	Shanghai, CN
3020664622	Pneumeric, Inc.	Luverne, MN, US
3005748921	ISCON SURGICALS, LTD.	JODHPUR Rajasthan, IN
9616662	MERIT MEDICAL IRELAND, LTD	Galway, IE
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044777128. Last updated year: 2026. Please use registration number 3044777128 when referencing this establishment in official correspondence.