Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005327291

FEI Number

3005327291

Entity Name

SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

Rm2004 B/D3 ,183 Huaihai xi Rd, SHANGHAI 200030, CN

Establishment Type(s)

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

Owner / Operator

SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. (Owner Number: 9078839)

Owner / Operator Contact Address

Rm2004 B/D3 ,183 Huaihai xi Rd, SHANGHAI, CN-SH 200030, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Irrigation Syringe ISOLATION GOWN GOWN Ice Bag Stockinette Mucus Extractor TRACHEAL TUBE DISH COLOSTOMY BAG Colostomy Bag BEDPAN STETHOSCOPE Scalpel Blade Tongue Depressor Vaginal Douche CAP Cotton Roll SHOE COVER Applicator Ear Ulcer Syringe Breast Pump Catheter SPECIMEN CONTAINER Air Cushion Electrode Adhesive Bandage Umbilical Cord Clamp Nasal Oxygen Cannula Nebulizer EYE PAD SCISSORS irrigation catheter Injection Site URINAL SCRUB SUITS PATIENT KIT Urine Bag FINGER SPLINT Gauze Face Mask Orthopedic Cast Padding Microscope Slide Alcohol Prep Pad Scalpel with handle Surgical Mask Elastic Bandage Hot Water Bag Cervical Scraper TONGUE DEPRESSOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2007-05-04
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-01-23
FME	Gown, Examination	General Hospital	Class 1	880.6265	2006-01-25
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2006-03-21
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2006-03-21
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2010-01-26
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2010-10-25
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2006-03-21
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2009-09-18
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2010-10-25
FOB	Bedpan	General Hospital	Class 1	880.6730	2009-09-24
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2006-03-21
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2005-10-24
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2006-01-25
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2006-03-21
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2006-01-25
EFN	Cotton, Roll	Dental	Class 1	872.6050	2009-09-18
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2006-01-25
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2006-03-21
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2006-03-21
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2006-03-21
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2006-03-21
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2007-05-04
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2006-03-21
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2008-01-07
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2006-03-21
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2007-05-04
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2016-01-29
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2009-09-24
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2006-01-25
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2007-06-12
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2007-07-19
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2010-10-25
FNP	Urinal	General Hospital	Class 1	880.6730	2015-11-14
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-18
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2005-10-24
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-08-18
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2006-01-25
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2006-03-21
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2005-10-24
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2006-03-21
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2007-05-04
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2017-02-18
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-10-18
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-10-24
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2006-03-21
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2016-03-18
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2005-10-24

Official Correspondent

Peter Zhang

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

SHANGHAI NEO-MEDICAL IMPORT & 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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

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2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005327291. Last updated year: 2026. Please use registration number 3005327291 when referencing this establishment in official correspondence.