Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009931872

FEI Number

3009931872

Entity Name

ZHANGJIAGANG MUNICIPAL CNNC HUAKANG RADIATION CO.,LTD.

City/State/Country

Zhangjiagang Jiangsu, CN

Establishment Address

88 Chuangye Rd, Fenghuang Town, Zhangjiagang Jiangsu 215614, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Zhangjiagang Municipal CNNC Huakang Radiation Co.,LTD. (Owner Number: 10052689)

Owner / Operator Contact Address

88 Chuangye Rd, Fenghuang Town, Zhangjiagang, CN-JS 215614, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FORCEPS Non-adherent pad roll gauze sterile first-aid dressing bandage PET Bandage Sterile label sling arm Non-woven swabs easyEndoTM Lite Linear Cutting Stapler and Loading Unit for Single Use Adhesive bandage Abdominal pads Roll gauze FIRST AID KIT Packing strip Compress bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-09-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-09-12
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2016-09-12
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2016-09-20
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2016-09-20
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-09-20
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-01-21
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-01-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-09-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-09-20
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2016-09-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-09-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-09-20

Official Correspondent

Minlei Zheng

US Agent Details

Solomon Chen Email: regmed.connect@gmail.com Phone: (909) 4387898

Related Public Records

Same Entity

Zhangjiagang Municipal CNNC Huakang Radiation 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K131563	Opus Ksd, Inc.	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	2014-04-09
K131705	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	2013-07-01

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.

Similar Registrations

Registration Number	Establishment Name	Location
3005374323	SPECTRUM SURGICAL SUPPLIES	SIALKOT Punjab, PK
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035678069	MATTES INSTRUMENTE GMBH	Tuttlingen-Nendingen Baden-Wurttemberg, DE
1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
1123010	TRINITY STERILE, INC.	SALISBURY, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009931872. Last updated year: 2026. Please use registration number 3009931872 when referencing this establishment in official correspondence.