Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011276993

FEI Number

3011276993

Entity Name

BIOSTECH CO., LTD.

City/State/Country

Eumseong-gun Chungbuk, KR

Establishment Address

274-46, Wonnamsandan-ro, Wonnam-myeon, Eumseong-gun Chungbuk 27721, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIOSTECH CO., LTD. (Owner Number: 10061536)

Owner / Operator Contact Address

274-46, Wonnamsandan-ro, Wonnam-myeon, Eumseong-gun, KR-43 27721, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Canker Relief (Model: CR12) OraCare (Models: CR12, OB23, OB53) Curatick (Models: CR12, CR23, CR53)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2019-10-28

Official Correspondent

SangWoon Kwak

US Agent Details

RYAN HWANG Business: INNO SENSE, INC. Email: ryan.s.hwang@hotmail.com Phone: (201) 4319052

Related Public Records

Same Entity

BIOSTECH 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 3011276993. Last updated year: 2026. Please use registration number 3011276993 when referencing this establishment in official correspondence.