Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004941127

FEI Number

3004941127

Entity Name

LINHAI DEYI PLASTIC CO., LTD

City/State/Country

Linhai City Zhejiang, CN

Establishment Address

No. 17-1, Binhai First Avenue, Shangpan Town, Linhai City Zhejiang 317015, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

LINHAI DEYI PLASTIC CO., LTD (Owner Number: 9069276)

Owner / Operator Contact Address

No. 17-1, Binhai First Avenue, Shangpan Town, Linhai City, CN-ZJ 317015, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal Aspirator EAR ULCER SYRINGE SYRINGE IRRIGATING (NON DENTAL) TOWEL CLAMP CLAMP NON-STERILE GENERAL HOSPITAL CONTAINER SPECIMEN NON-STERILE SPECIMEN AMSmooth Amsino SPECULUM VAGINAL NONMETAL TRAY SURGICAL CULTRUE DISH FIBER, MEDICAL, ABSORBENT TRAP STERILE SPECIMEN FORCEPS SPONGE BRUSH TRAY SURGICAL INSTRUMENT Disposable Vaginal Speculum SPECULUM VAGINAL NONMETAL MEDICINE CUP CONTAINER LIQUID MEDICATION GRADUATED

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	2006-04-10
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2006-04-10
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2006-05-01
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2008-08-25
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-04-10
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2006-06-06
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2006-04-10
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2006-04-10
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-04-10
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2006-04-10
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2006-06-06
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2010-02-20
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2006-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

Mukesh Kumar Business: Brij Strategic Consultations, LLC Email: mkumar@FDAMap.com Phone: (240) 7504893

Related Public Records

Same Entity

LINHAI DEYI PLASTIC 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
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-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3012070313	Nupur Technologies	Buffalo, NY, US
3027473313	ZHEJIANG HOPE PHARMA LTD	Wenzhou Zhejiang, CN
3044994756	SUNMED AP, LTD., WAREHOUSE NO. 2	ZHUHAI Guangdong, CN
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 3004941127. Last updated year: 2026. Please use registration number 3004941127 when referencing this establishment in official correspondence.