JIANGSU QIANTAI MEDICAL INSTRUMENT CO., LTD.

FDA Device Registration & Listing · Tai zhou Jiangsu, CN · Registration 3030226294

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
3030226294
FEI Number
3030226294
Entity Name
JIANGSU QIANTAI MEDICAL INSTRUMENT CO., LTD.
City/State/Country
Tai zhou Jiangsu, CN
Establishment Address
Building 9, Medical Equipment Area Phase I standard factory, No. 898 Yaocheng Avenue, Taizhou Pharmaceutical high-tech Industrial Development Zone, Tai zhou Jiangsu 225300, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Jiangsu Qiantai Medical Instrument Co., Ltd. (Owner Number: 10089268)
Owner / Operator Contact Address
Building 9, Medical Equipment Area Phase I standard factory, No. 898 Yaocheng Avenue, Taizhou Pharmaceutical high-tech Industrial Development Zone, Tai zhou, CN-JS 225300, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Silicone scar sheets Hydrogel chest seal, Panty tape, Surgical film (antibacterial) Acne patch, Zinc oxide tape, Israeli bandage, Hernia patch Silicone gel foam dressing, Indwelling needle sticker, Bandage, Hydrocolloid roll Fever cooling patch Gel dressing for burns, PU film roll, Sterile dressing Hydrocolloid dressing Medical gauze, Compression curve gauze, Cotton sheet, Kaolin hemostasis gauze, Plaster bandage Clamp tourniquet, A spinning tourniquet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PFP Silicone Hydrogel For Scar Management General, Plastic Surgery Class 1 878.4025 2026-03-31
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2023-11-22
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2023-11-22
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2023-11-22
OMW Adhesive Backed Thermal Skin Patches Physical Medicine Class 1 890.5710 2023-11-22
MHW Dressing, Compression General Hospital Class 1 880.5075 2023-11-22
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2023-11-22
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2023-11-22
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2023-11-22

Official Correspondent

Huihui Lu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jiangsu Qiantai Medical Instrument 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
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 3030226294. Last updated year: 2026. Please use registration number 3030226294 when referencing this establishment in official correspondence.
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