Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015220159

FEI Number

3015220159

Entity Name

PRIME WATER CO.,LTD.

City/State/Country

Bucheon-si Gyeonggi, KR

Establishment Address

#901-301, 345, Seokcheon-ro, Bucheon-si Gyeonggi 14501, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Prime Water Co.,Ltd. (Owner Number: 10060329)

Owner / Operator Contact Address

#901-301, 345, Seokcheon-ro, Bucheon-si, KR-41 14501, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prime-L CERA CARE CHM-7 Prime-R Prime-RV Prime-LC11 Prime-S Prime-LV Prime Prime-V CERA CARE CHM-5 Prime-SV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2019-04-26

Official Correspondent

No official correspondent registered.

US Agent Details

Grace Kim Business: J.S.Chem International Co. Email: gracejschem@hotmail.com Phone: (310) 5983012

Related Public Records

Same Entity

Prime Water 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 3015220159. Last updated year: 2026. Please use registration number 3015220159 when referencing this establishment in official correspondence.