Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016901080

FEI Number

3016901080

Entity Name

T&R BIOFAB CO.,LTD.

City/State/Country

Siheung-si Gyeonggi, KR

Establishment Address

96, Mayu-ro, Siheung-si Gyeonggi 15111, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

T&R BIOFAB CO.,LTD. (Owner Number: 10082367)

Owner / Operator Contact Address

96, Mayu-ro, Siheung-si, KR-41 15111, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SurgiAngel, SurgiCure Reproderm-gel TnR Foam A Band Bonofoam S Band Bonofoam A Band TnR Foam S Band SurgiCure S Elastonz-gel S SurgiAngel S Reproderm-gel S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-05-10
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-04-08
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2024-04-08

Official Correspondent

Wonsoo Yun

US Agent Details

Edward PARK Business: Lighten Bridge LLC Email: lightenbridge@gmail.com Phone: (972) 8000044

Related Public Records

Same Entity

T&R BIOFAB CO.,LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016901080. Last updated year: 2026. Please use registration number 3016901080 when referencing this establishment in official correspondence.