TAIZHOU CHENGUANG IMPORT AND EXPORT TRADING CO., LTD.

FDA Device Registration & Listing · Taizhou Jiangsu, CN · Registration 3012680643

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
3012680643
FEI Number
3012680643
Entity Name
TAIZHOU CHENGUANG IMPORT AND EXPORT TRADING CO., LTD.
City/State/Country
Taizhou Jiangsu, CN
Establishment Address
Room 401, Building 6, 36 Gutian Road, Jiangyan, Taizhou Jiangsu 225500, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Taizhou Chenguang Import and Export Trading Co., Ltd. (Owner Number: 10061679)
Owner / Operator Contact Address
Room 401, Building 6, 36 Gutian Road, Jiangyan, Taizhou, CN-JS 225500, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2026-06-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2026-06-11
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2026-06-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2026-06-11
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2026-06-10
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2020-04-09
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2020-04-09
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2020-04-09
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2020-04-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-06-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-06-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-06-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-04-09
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2026-06-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-06-10
PFP Silicone Hydrogel For Scar Management General, Plastic Surgery Class 1 878.4025 2026-06-10
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2026-06-10
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2020-04-09
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2020-04-10
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2026-06-11
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2026-06-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2020-04-09
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2026-06-10
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2026-06-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-04-09
OMW Adhesive Backed Thermal Skin Patches Physical Medicine Class 1 890.5710 2026-06-10
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2020-04-09
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-03-10
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2020-04-10

Official Correspondent

Heping Ding

US Agent Details

Robert James Email: robertkelii@gmail.com Phone: (808) 2564839

Related Public Records

Same Entity

Taizhou Chenguang Import and Export Trading 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
K831001 Frontier Products UNICUFF-BLOOD PRESSURE CUFF 1983-07-28
K253089 Shenzhen Best Electronics Co., Ltd. NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) 2026-02-13
K972301 Rudolf Riester GmbH & Co. KG BIG BEN SQUARE, BIG BEN ROUND 1997-09-17
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24

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 3012680643. Last updated year: 2026. Please use registration number 3012680643 when referencing this establishment in official correspondence.
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