Suzhou CNNC Huadong Radiation Co.,Ltd

FDA Device Registration & Listing · SUZHOU Jiangsu, CN · Registration 3004080548

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004080548
FEI Number
3004080548
Entity Name
Suzhou CNNC Huadong Radiation Co.,Ltd
City/State/Country
SUZHOU Jiangsu, CN
Establishment Address
4756 # Jiaotong Road, Wujiang DIstrict, SUZHOU Jiangsu 215200, CN
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Suzhou CNNC Huadong Radiation Co.,Ltd (Owner Number: 9057083)
Owner / Operator Contact Address
4756# Jiaotong Road, Wujiang DIstrict, Suzhou, CN-JS 215200, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

hydrocolloid dressing, AFD01(5cmx5cm) hydrocolloid dressing, AFD30(5cmx5cm) nonwoven pad, alcohol pad tubes Ostomy bags KL20 Series Pre-filled Normal Saline Flush Syringe bloodstopper,dressing,compression

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2011-12-19
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2020-07-02
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2012-12-05
FRO Dressing, Wound, Drug Unknown Class U N/A 2016-06-27
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2012-12-26
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2012-12-26
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2015-01-07
KJG Tube, Tissue Culture Pathology Class 1 864.3010 2015-04-20
FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology Class 1 876.5900 2016-08-11
FQM Bandage, Elastic General Hospital Class 1 880.5075 2012-12-26
NGT Saline, Vascular Access Flush General Hospital Class 2 880.5200 2022-11-09
MHW Dressing, Compression General Hospital Class 1 880.5075 2015-04-13

Official Correspondent

Jun Gu

US Agent Details

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

Related Public Records

Same Entity

Suzhou CNNC Huadong 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
K130132 Medipurpose Pte. , Ltd. BABYLANCE HEEL INCISION DEVICE 2013-02-11
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0044-2008 Becton Dickinson & Company 2
Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004080548. Last updated year: 2026. Please use registration number 3004080548 when referencing this establishment in official correspondence.
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