Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015821396

FEI Number

3015821396

Entity Name

JCMED TIANJIN IMPORT AND EXPORT CO., LTD

City/State/Country

Tianjin, CN

Establishment Address

418-419 Room, Yuanhang Business Center, Lucia Commercial Street, Airport Economic Zone, Tianjin 300300, CN

Establishment Type(s)

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

Owner / Operator

JcMed TIANJIN Import and Export Co., Ltd (Owner Number: 10081379)

Owner / Operator Contact Address

418-419 Room, Yuanhang Business Center, Lucia Commercial Street, Airport Economic Zone, Tianjin, CN-TJ 300300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Venturi mask Cotton Tape; Silicone Tape; Foam Tape; PU tape; Muscle Tape; Adhesive Bandage; Skin Closure Strips; Surgical Tape; PE Tape; Non-woven Tape; Silk Tape; Spunlaced Non-woven Tape; Fixing Tape; Zinc-oxide Tape; Tapes; Adhesive Tape; Medical Tape; Kinesio Tape; Kinesiology Tape; Muscle Tape; Sports Tape; Elastic Tape Oropharyngeal Airway Amorphous Hydrogel Dressing; Burn Dressing; Hydrogel Gauze; Hydrogel Medical Dressing Alginate with Silver Dressing Cannula Foam Dressing; Honey Gauze Dressing; Oil Emulsion Dressing; Petrolatum Dressing; Silicone Foam Dressing; Nonwoven Wound Dressing; Super Absorbency Dressing; Silicone Wound Contact Dressing; Silicone Dressing Scarcin Pad; Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Silicone Dressing; NPWT Dressing Silicone Gel Scar Dressing; Silicone Gel Sheet; Gelling Fiber Dressing; Chest Seal; Transparent Dressing; Nasal oxygen Wound Dressing Kit Breathing Exerciser; Lung Trainer; One Ball Spirometer; Respiratory Excerciser; Respiratory Meter;Three Balls Spirometer Radiographic protective glove - Gloves Wound Closure Device Tourniquet Ear wash ball Nebulizer kit Nasal irrigator Chest Drainage Catheter Adhesive Wound Dressing; Sterile Gauze Pad; ABD Pad; Non-Adherent Wound Pad; Gauze Roll; Gauze Swab; Gauze Bandage; Absorbent Pad; Combine Pad; Gauze Sponge; Non Adherent/Wound Dressing Pad; Foam Pad; Soluble Hemostatic Gauze; Gauze Ball Oxygen mask Saliva Collection Endotracheal Tube, Catheter Fixation Kit Alginate dressing, Foam Dressing Set, Hydrophilic Dressing, Wound Plaster, Non Woven Dressing, Foam Dressing, Acne Patc First Aid Kit Urine Drainage Bag, Urine Collector, Urine Bag, Plastic Parts, Urine Bag And Accessories, Catheter Valve, Extension Tube Surgical drape Catheter Valve, Extension Tube Disposable Use of Drainage Bag, Non-Sterile Urine Collection Bag, leg bag (urine), Leg Bags And Accessories, Skin protector paster, Hydrocolloid skin barrier, Skin protective power, Anti-leakage strip, Hydrocolloid skin protective ring First aid kit with drug

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2025-07-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-04-15
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2025-07-08
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2022-05-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-07-08
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2025-07-08
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-05-18
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-07-08
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2025-12-12
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2025-07-08
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2025-07-17
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2021-04-08
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-08-26
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2025-07-08
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2025-07-08
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2025-07-08
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-07-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-04-15
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2025-07-08
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2025-12-12
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2025-07-08
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2023-09-12
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2022-05-18
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2023-09-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-07-08
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2023-09-12
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-07-08
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2023-09-12

Official Correspondent

Allan Zhang

US Agent Details

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

Related Public Records

Same Entity

JcMed TIANJIN Import and Export 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

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-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
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.

Similar Registrations

Registration Number	Establishment Name	Location
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3014208300	HITEC MEDICAL CO., LTD	Shanghai, CN
3016458361	SHAOXING REBORN MEDICAL DEVICES CO.,LTD	Shaoxing Zhejiang, CN
3031369651	HSINER CO., LTD.	Taichung City, TW
3004134948	ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.	Huzhou City Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015821396. Last updated year: 2026. Please use registration number 3015821396 when referencing this establishment in official correspondence.