Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008485841

FEI Number

3008485841

Entity Name

YANCHENG TRANCOM FIRST AID SUPPLIES INDUSTRIAL CO., LTD

City/State/Country

Yangcheng Jiangsu, CN

Establishment Address

No. 8 West Fuling Road, Yangma Town, Sheyang, Yangcheng Jiangsu 224335, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Yancheng Trancom First Aid Supplies Industrial Co., Ltd (Owner Number: 10032998)

Owner / Operator Contact Address

No. 8 West Fuling Road, Yangma Town, Sheyang, Yangcheng, CN-JS 224335, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Saline Bandage shears Glove Skin cleaning wipes Non-adherent wound dressing Conforming bandage First aid kit Resuscitation face mask Ice pack, Hot pack Combine dressing Tweezers Wound closures Torch Isolation Gown Antiseptic Personal Protective Mask Nitrile Gloves Hypo allergenic adhesive tape Wound dressing body patches Gauze roll

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IGC	Formalin-Saline	Pathology	Class 1	864.4010	2010-07-01
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-07-01
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2010-07-01
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2010-07-01
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2010-07-01
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2010-07-01
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2010-07-05
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2010-07-01
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2010-07-01
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2010-07-01
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2010-07-01
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2010-07-01
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2010-07-01
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-12
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2010-07-01
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2010-07-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2010-07-01
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2010-07-01
EFN	Cotton, Roll	Dental	Class 1	872.6050	2010-07-01

Official Correspondent

Yang Chen

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Yancheng Trancom First Aid Supplies Industrial 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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
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.

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8010298	RUDOLF MEDICAL GMBH + CO. KG	FRIDINGEN Baden-Wurttemberg, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008485841. Last updated year: 2026. Please use registration number 3008485841 when referencing this establishment in official correspondence.