Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017676140

FEI Number

3017676140

Entity Name

SYNOPEX BIOFILTER

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

54-42, Dongtanhana 1-gil, Hwaseong-si Gyeonggi 18423, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SYNOPEX BIOFILTER (Owner Number: 10078178)

Owner / Operator Contact Address

54-42, Dongtanhana 1-gil, Hwaseong-si, KR-41 18423, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SYNOTEX MASK (White) SYNOPEX ABSOLUTE MB MASK (Pink) SYNOPEX ABSOLUTE MB MASK (White) SYNOTEX MASK (Dark Gray) SYNOTEX MASK (Beige) SYNOTEX MASK (Pink) SYNOPEX ABSOLUTE MB MASK (Beige) SYNOPEX ABSOLUTE MB MASK (Light Pink) SYNOTEX MASK (Black) SYNOPEX ABSOLUTE MB MASK (Khaki) SYNOPEX ABSOLUTE MB MASK (Light Gray) SYNOTEX MASK (Light Gray) SYNOTEX MASK (Light Pink) SYNOPEX ABSOLUTE MB MASK (Black) SYNOPEX ABSOLUTE MB MASK (Dark Gray) Absolute Water Purifier(PRO)(Black) Absolute Water Filter for Purifier(max)(Black) Absolute Water Purifier(MAX)(Black) Absolute Water Purifier(PRO)(White) Absolute Water Filter for Purifier(pro)(White) Absolute Water Filter for Purifier(pro)(Black) Absolute Water Filter for Purifier(head)(White) Absolute Water Purifier(MAX)(White) Absolute Water Filter for Purifier(max)(White) Absolute Water Filter for Purifier(head)(Black)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-10-13
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2023-03-02

Official Correspondent

Ha-Na Lee

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

SYNOPEX BIOFILTER

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 3017676140. Last updated year: 2026. Please use registration number 3017676140 when referencing this establishment in official correspondence.