Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015140210

FEI Number

3015140210

Entity Name

JIANGSU OSTUP MEDICAL PRODUCTS CO. LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

No.9, Caofang Road, Longchi Street, Luhe District, Nanjing Jiangsu 210044, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Jiangsu Ostup Medical Products Co. Ltd. (Owner Number: 10059144)

Owner / Operator Contact Address

No.9, Caofang Road, Longchi Street, Luhe District, Nanjing, CN-JS 210044, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Body Surface Conduit Fixing Device Silicone Foam Dressing Ostomy baseplate Hydrocolloid adhesive bandage,Acne pacth Ostomy Paste, Ostomy Powder, skin protective film, Ostomy Belt, Ostomy Barrier Ring Hydrocolloid dressing Collection Bottle Elastic Barrier Tape Urine bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2024-11-07
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-12-04
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-12-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-12-04
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-12-04
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-12-04
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-11-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-11-07
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2018-12-04

Official Correspondent

Jucy Wu

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Ostup Medical Products 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.

Similar Registrations

Registration Number	Establishment Name	Location
3016112560	SECURISYN MEDICAL, LLC	Littleton, CO, US
3004472848	VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED	ZHANGJIAGANG Jiangsu, CN
3007483335	Qingdao Leckie Foam Products Co. Ltd.	Qingdao Shandong, CN
3024808683	WARRIORNP LLC	Bloomfield Hills, MI, US
1824231	ICU Medical, Inc.	Gary, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015140210. Last updated year: 2026. Please use registration number 3015140210 when referencing this establishment in official correspondence.