Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616572

FEI Number

3003661715

Entity Name

TRONJEN MEDICAL TECHNOLOGY INC

City/State/Country

Nantun Dist. Taichung, TW

Establishment Address

5F, No. 63, Jingke Central road, Nantun Dist. Taichung 408018, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

TRONJEN MEDICAL TECHNOLOGY INC (Owner Number: 10022940)

Owner / Operator Contact Address

5F, No. 63, Jingke Central road, Nantun Dist, TW-TXG 408018, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Hydrogel Dressing Waterproof Island Dressing Hydrocolloid Dressing Foam Dressing Waterproof Film Dressing Gauze Pad Foam Dressing Skin Barrier Pressure relief pad Hydrogel wound dressing H&H Wound Gel Wound Gel Hydrocolloid Dressing GelSkin H&H Hydrogel wound dressing Comfopore Surgical skin degreaser or adhesive tape solvent Adhesive Release Spray Waterproof Bandage First Aid Tape Plaster Strip First Aid kits Waterproof Island Dressing Waterproof Film First Aid Bandage Hydrogel Wound Dressing Surgical Hydrogel Dressing Hydrocolloid bandage Hydrocolloid Dressing GelSkin Comfopore Dressing Retaintion Roll Plaster for Knuckles and Fingers Island Dressing Plaster for Eye

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-05-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-05-23
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2022-07-15
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2019-12-26
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2019-12-24
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-07-15
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2024-02-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-10-24

Official Correspondent

Sunny Ku

US Agent Details

Baosheng Lee Business: Baoni International Inc. Email: lee.baoni@outlook.com Phone: (678) 4676822

Related Public Records

Same Entity

TRONJEN MEDICAL TECHNOLOGY INC

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616572. Last updated year: 2026. Please use registration number 9616572 when referencing this establishment in official correspondence.