Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009308092

FEI Number

3009308092

Entity Name

SUZHOU PIPI MEDICAL PRODUCTS CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.139 WeiHe Road, #2 Building, 7th Floor, SuZhou Industries Park, Suzhou Jiangsu 215122, CN

Establishment Type(s)

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

Owner / Operator

SuZhou PiPi Medical Products Co., Ltd (Owner Number: 10037836)

Owner / Operator Contact Address

No.139 WeiHe Road,, #2 Building, 7th Floor, SuZhou Industrial Park, Suzhou, CN-JS 215122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VAGINAL SPECULUM Bib Tongue Cleaner FOIL BABY BUNTING STERILE Underpad Reacher PILL CRUSHER PILL CUTTER Face Shield Disposable Forehead Thermometer Strip Post Op Shoe Baby Footprinter Toothbrush Isolation Gown Bath sponge Wooden Tongue Deperessors SAMMONS PRESTON UNV REPLACE ARM PAD FULL Digital Thermometer Waste Bag Razor Natural Sheepskin First Aid Kit Bulb Syringe Ear/Ulcer Syinge Disposable Umbilical Scissors SPECTACLE, MAGNIFYING Diabetic foot test monofilament Bra Pads; Breast Pads; Disposable Bra Pads; Disposable Breast Pads; Disposable Nursing Pads; Nursing Pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2023-02-06
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2011-08-24
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2011-08-24
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2021-06-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2011-08-24
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2017-02-22
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2022-04-17
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2014-11-21
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2011-08-24
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2011-08-24
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2011-08-24
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2012-06-18
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-20
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2020-05-26
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2015-03-15
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2011-08-24
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2012-06-18
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-01-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2011-08-24
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2011-08-24
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2011-08-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2011-08-24
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2011-08-24
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2022-08-17
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2011-08-24
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2025-05-07
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2023-04-06
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2015-09-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-08-11
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2021-06-03
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-08-24
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2016-07-14
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2021-02-03
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2016-02-16
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2011-08-24
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2011-08-24
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-08-24
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2025-02-04
GXB	Esthesiometer	Neurology	Class 1	882.1500	2021-03-29
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2023-02-06

Official Correspondent

Paolo Long

US Agent Details

Paul Rollinson Business: Rollinson Associates Email: paulrollinson@sbcglobal.net Phone: (860) 9285147

Related Public Records

Same Entity

SuZhou PiPi Medical Products 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
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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009308092. Last updated year: 2026. Please use registration number 3009308092 when referencing this establishment in official correspondence.