Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011715922

FEI Number

3011715922

Entity Name

SUZHOU PULIKANG MEDICAL DEVICE CO LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

NO. 80 Zhenhong Road, Renyang Industrial Park, Changshu, Suzhou Jiangsu 215539, CN

Establishment Type(s)

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

Owner / Operator

Suzhou Pulikang Medical Device Co Ltd (Owner Number: 10049415)

Owner / Operator Contact Address

NO. 80 Zhenhong Road, Renyang Industrial Park, Changshu, Suzhou, CN-JS 215539, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile eye wash Carbon Fiber Wound Dressings Wound Pad Chitin Wound Dressings Foam Dressings Calcium Alginate Wound Dressings Combine Dressing Splinter Probe Finger Cot Foil Thermal Blanket Cooling Gel Sheet, Instant Ice Pack Eye Pad Safety pins Elastic bandage Tweezers Antiseptic Wipes Sting Relief Pads Alcohol Wipes Medical PREP Pad CPR Face Shield Hydrogel dressing Chest seal Burn Gel Packets Thermometer strip Hemostasis Pad Tourniquet First Aid Kit without drug Triangular Bandage Tongue depressor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2018-07-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2015-05-28
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2022-06-27
LZB	Finger Cot	General Hospital	Class 1	880.6250	2024-12-31
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2018-07-04
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2015-08-09
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2018-07-04
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2018-07-04
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-08-09
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-07-04
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2018-07-04
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-07-04
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-07-04
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2024-12-31
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2015-08-09
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-07-03
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2018-07-04
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2024-12-31

Official Correspondent

Min Xu

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (920) 6019045

Related Public Records

Same Entity

Suzhou Pulikang Medical Device 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011715922. Last updated year: 2026. Please use registration number 3011715922 when referencing this establishment in official correspondence.