Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012002722

FEI Number

3012002722

Entity Name

PRO-MED (WUXI)IMP.& EXP.CO.,LTD.

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

No.282 Changjiang North Rd, Xinwu District,, Wuxi Jiangsu 214000, CN

Establishment Type(s)

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

Owner / Operator

Pro-Med (Wuxi)Imp.& Exp.Co.,Ltd. (Owner Number: 10085601)

Owner / Operator Contact Address

No.282 Changjiang North Rd, Xinwu District,, Wuxi, CN-JS 214000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bag, Drainage, With Adhesive, Drainage Bag, Ostomy bags Airway, Oropharyngeal, Anesthesiology-Disposable PVC/Reinforced PVC Laryngeal Mask Airway, Disposable /Reusable Silicone Laryngeal Mask Airway Identification bracelets Bandage, Elastic-Adhesive Elastic Bandage, Cotton Elastic Bandage, Crepe Bandage, Elastic Bandage Bandage Blade, Scalpel-Surgical Blades, Surgical Blades with Plastic Handle Gauze /Sponge, Non resorbable For External Use - Abdominal Pads; Gauze Bandages; Gauze Compresses; Gauze Rolls; Compressed sponge sheet, Spong stick (swab), Nylon brush scrub clean brush, cotton applicator, surgical drape, lap sponge, cast padding Gauze Sponges; Medical Gauze, Gauze roll, Gauze piece, Gauze pad, Gauze bandage Sponge brush, Surgical Scrub brush, Tape and Bandage, Adhesive-Adhesive Elastic Bandage, Non-Woven Tape, PE Tape, Silk Tape, Zinc Oxide Adhesive Plaster Enema Kit Feeding bag, Enteral Feeding bag, Enteral Feeding set, Enfit syringe, Feeding Tube Accessory, Surgical Apparel - Nurse Bouffant Cap, Patient`s Gowns, Pillow Case, Shoes Cover, Surgeon Cap Nebulizer Face Mask Condenser. Heat And Moisture (Artificial Nose)- HMEs-Heat and Moisture Exchange Filters, HME For Tracheostomy Patient Syringe, Irrigating (Non-Dental) -Disposable Syringes, General Hospital syringe Cannula, Nasal, Oxygen-Nasal Cannula Catheter, Infusion-Catheter for Infusion, Extension Tube Silicone/SEBS/PVC Manual Resuscitators (Oxygen Tube) Silicone/SEBS/PVC Manual Resuscitators (Reservoir); Silicone/SEBS/PVC Manual Resuscitators (Mask); Regulator, Pressure, Gas Cylinder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-12-16
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2022-07-08
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2023-12-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-07-08
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-07-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-12-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-07-08
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2025-12-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-07-08
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2023-12-20
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2022-07-08
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2022-07-08
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2022-07-08
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2022-07-08
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2022-07-08
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2024-12-13
ECX	Cylinder, Compressed Gas, And Valve	Anesthesiology	Class 1	868.2700	2023-12-20

Official Correspondent

Yong an Zhao

US Agent Details

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

Related Public Records

Same Entity

Pro-Med (Wuxi)Imp.& Exp.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
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-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3019865496	Dongguan Kangda Medical Technology Co., Ltd	Dongguan Guangdong, CN
3010198795	Shanghai Joy Crown Industry Co., Ltd	Pu Dong New Area Shanghai, CN
3014351477	STIEHL TECH	Lisle, IL, US
3005621808	ANJI HONGDE MEDICAL PRODUCTS CO., LTD.	HUZHOU Zhejiang, CN
3006517436	ZHEJIANG KANG LI DI MEDICAL ARTICLES CO., LTD.	YUEQING CITY Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012002722. Last updated year: 2026. Please use registration number 3012002722 when referencing this establishment in official correspondence.