Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005216199

FEI Number

3005216199

Entity Name

Biontech Life Co., Ltd

City/State/Country

Gunpo-si Gyeonggi, KR

Establishment Address

298-15, Gongdan-ro (Geumjeong-dong), Gunpo-si Gyeonggi 15809, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biontech Life Co., Ltd (Owner Number: 10023846)

Owner / Operator Contact Address

298-15, Gongdan-ro (Geumjeong-dong), Gunpo-si, KR-41 15809, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BTM-200N, BTM-100N, BTM-102G, BTM-300N, BIONTECH 500, BTM-400N, BTM-600N, BTM-800 BTC-3000, BTC-1000 BTM-700, BTM-900, BTM-8000, BTM-7000, BTM-5000, BTM-4000, BTM-3000, BTM-2000, BTM-1000 BTM-101E, BTM-101T&S, BTM-102F, BTM-505N, BTM-202L, BTM-105D, BTM-105U, BTM-103D BTM-701T, BTM-501T, BTM-207E, BTM-303, BTM-207D, PRIME GOLD BTM-503 BTM-303D BTM-1200 BTM-1100 BTM-1700C BTM-1800 BTM-1800HC BTM-1700 BTM-1600 BTH-550 Platinium BTC-5006 BTS-1000 BTH-1600 BTH-1000 BTH-101T BTM-1700H BTM-1500 BTM-1700HC BTH-600 BTM-701K BTH-200 BTM-1800H BTH-1400 BTF-200 BTM-7003 BTM-2200 BTM-1800C BTH-1300 BTC-5005 BTM-7004 BTM-7002 BTM-501K BTH-100P BTM-2100 BTF-100 BTH-1500 BTM-305 BTM-7001 BTM-507

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	2007-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Krallum Uju Business: Onbix Corp US Email: onbixus@gmail.com Phone: (843) 5828036

Related Public Records

Same Entity

Biontech Life Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3019916040	NUVE SANAYI MALZEMELERI IMALAT VE TICARET A.S.	ANKARA, TR
3014345255	GUANGDONG JUNFENG BFS TECHNOLOGY CO., LTD.	guangzhou Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005216199. Last updated year: 2026. Please use registration number 3005216199 when referencing this establishment in official correspondence.