Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015140199

FEI Number

3015140199

Entity Name

JIANGSU WLD MEDICAL CO., LTD.

City/State/Country

YIZHENG Jiangsu, CN

Establishment Address

NO.138, XISHAN SOUTH ROAD, CHENJI TOWN, YIZHENG Jiangsu 211408, CN

Establishment Type(s)

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

Owner / Operator

JIANGSU WLD MEDICAL CO., LTD. (Owner Number: 10059126)

Owner / Operator Contact Address

NO.138 XISHAN SOUTH ROAD, CHENJI TOWN, YIZHENG, CN-JS 211408, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-surgical isolation gown Disposable Syringe Sterile alcohol prep pads Ostomy Baseplate Sterile alcohol prep pads Disposable non-woven face mask; Non-woven cap; Nurse BOUFFANT cap; Patient's gowns; Pillow case; Cotton Filled Gauze; Gauze Bandage; Gauze Roll; Gauze Sponge; Non Woven Swab Hydrocolloid Adhesive Bandage, Acne Patch Face Mask COTTON SWAB, COTTON BALL & COTTON ROLL IV Cannula Ostomy Paste, Ostomy Powder, Skin Protective Film Patient ID Bracelet Urine Bag Bedding, disposable, medical - emergency rescue blanket Disposable Underpad Examination Table Paper Roll SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE Disposable Syringe Micropore Nonwoven Tape Non-woven Cohesive Bandage with Latex Shoe Cover Hydrocolloid Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2018-12-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-15
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2026-04-21
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2018-12-03
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2021-05-16
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2026-04-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-12-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-12-07
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2018-12-05
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2018-12-07
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-12-07
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2021-05-16
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2019-06-25
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-12-03
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2018-12-05
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-08-24
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2018-12-07
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2018-12-07
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-12-07
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2021-05-16
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2024-05-13
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2021-05-16
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2018-12-07
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-12-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-11-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-11-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-12-07
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-12-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-12-07
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2018-12-05
LZB	Finger Cot	General Hospital	Class 1	880.6250	2018-12-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-12-07
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-12-05
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2018-12-03
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2018-12-03
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2018-12-07
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2021-05-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-12-07
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2018-12-05

Official Correspondent

Lily Yang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: Regrek.Cs@Hotmail.Com Phone: (302) 6089028

Related Public Records

Same Entity

JIANGSU WLD MEDICAL 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K221629	Covidien	Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)	2023-02-22
K231491	Covidien	TA Stapler and Loading Unit with DST Series Technology	2023-08-16
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015140199. Last updated year: 2026. Please use registration number 3015140199 when referencing this establishment in official correspondence.