Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016444419

FEI Number

3016444419

Entity Name

YUNBIOTECH CO.,LTD.

City/State/Country

Namdong-gu Incheon, KR

Establishment Address

86, Namdongseo-ro, Namdong-gu Incheon 21697, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

YUNbiotech Co.,Ltd. (Owner Number: 10062287)

Owner / Operator Contact Address

86, Namdongseo-ro, Namdong-gu, KR-28 21697, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STARFIX, F-Fix Finger G-Fix Ulnar Gutter G-Fix Cock Up (Wrist) STARFIX, F-Fix Hue Bio Grab Finger STARFIX, F-Fix Thumb 2 STARFIX, F-Fix Cock Up (Wrist) STARFIX, F-Fix Functional STARFIX, F-Fix Ulnar Gutter Bio Grab Hand G-Fix Cast Type G-Fix Thumb G-Fix Radial Gutter STARFIX, F-Fix Cast Type STARFIX, F-Fix Radial Gutter Bio Grab Thumb G-Fix Functional STARFIX, F-Fix Thumb STARFIX, F-Fix cylinder STARFIX, F-Fix Long Leg G-Fix Long Leg Bio Grab Cylinder G-Fix Cylinder Cast Shoes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2020-01-09
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-08-21
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2025-08-21

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

YUNbiotech 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 3016444419. Last updated year: 2026. Please use registration number 3016444419 when referencing this establishment in official correspondence.