Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012777736

FEI Number

3012777736

Entity Name

EMSRUN GROUP

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

8-7 Huide Road, Huishan Area, Wuxi Jiangsu 214000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMSRUN GROUP (Owner Number: 10052960)

Owner / Operator Contact Address

8-7 Huide Road, Huishan Area, 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

ice pack sterile eye pad Dry Bag Operating table antiseptic wipes,cleansing wipes alcohol prep pad, soap wipes, povidone iodine prep pads,iodine cotton ball,iodine cottonbar,iodine cotton towel alcohol cotton ball wipes medical scissor Piston Syringe with Needle mouth to mouth mask forceps,tweezers Stethoscope church Trolly Infusion set CPR mask,breathing mask Fingertip Oximeter Pelvis belt Wound dressing,transparent wound dressing dressing chest seal cervical Collar vacuum mattress stretcher,spine board, Evacuation Chair Stretcher, traction splint soft Stretcher,Isolation stretcher,Stretcher platform, stair stretcher, folding Stretcher ambulance Stretcher,scoop stretcher,basket stretcher,multifunctional rescue stretcher Carbon Fiber Scoop Stretcher cooling gel sheet Hemostatic Dressing emergency sleeping bag, emergency blanket, body bag Manual suction pump compress/pack,heat pack ice pack Toothbrush extrication device aluminum mouldable splint IV catheter Goggle first aid kit WITH DRUG finger splint Tactical Tourniquet tourniquet suction tube Camping bed,Hospital bed Packaging pouch, self-sealed sterilization pouch Protective suit ISOLATION Gown Nasopharyngeal Airway first aid kit, TRAUMA KIT Airway adhesive bandage, Israel wound dressing wound closures tape dressing pad gauze swabs rolled gauze compressed gauze Burn Gel Burn Dressing Lubricating Jelly Oxygen cylinder,oxygen regulator, oxygen Flow meter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2017-12-28
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2016-10-27
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2018-10-23
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2016-10-27
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2016-10-26
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-10-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-07-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2017-07-21
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2016-10-27
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-10-27
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2018-10-23
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2016-10-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-07-21
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2017-12-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-05-28
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2016-10-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-10-20
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2016-10-27
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2016-10-27
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2016-10-27
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-08-18
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-10-27
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2016-10-27
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2016-10-27
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-07-02
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2016-10-27
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2016-10-20
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2019-10-25
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-21
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2016-10-27
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-12-28
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2016-10-20
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2016-10-20
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2016-10-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-07-02
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-21
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2019-10-25
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2016-10-27
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-10-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-10-27
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-10-27
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2019-10-25
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2025-05-14
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2016-10-27

Official Correspondent

Weifeng Li

US Agent Details

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

Related Public Records

Same Entity

EMSRUN GROUP

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012777736. Last updated year: 2026. Please use registration number 3012777736 when referencing this establishment in official correspondence.