Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011585752

FEI Number

3011585752

Entity Name

HANGZHOU HAIZHU MIM PRODUCTS CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No.189 FengQi East Road, Hangzhou Zhejiang 310000, CN

Establishment Type(s)

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

Owner / Operator

Hangzhou HaiZhu MIM products Co., Ltd (Owner Number: 10058657)

Owner / Operator Contact Address

No.189 FengQi East Road, Hangzhou, CN-ZJ 310000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RETRACTOR needle, suturing, disposable. Cotton and Dressing Tweezers; splinter tweezers Forceps; Dressing forceps MYRTLE LEAF PROBE 5.75" SCALPEL HANDLE; Scalpel, Handle, teasing needle steel handle, FORCEPS, GENERAL & PLASTIC SURGERY Clip, Removable (Skin) Porbe Operating scissors; Scissors, General, Iris Scissors, Surgical (Various) DENTAL SURGERY SET / KIT ; Basic suture kit ; Basic surgical instruments kit / set ; BODY PIERCING INSTRUMENTS KIT / SET Ortho plier Scissors, Iris Scissors, Ophthalmic (Various) Breulaast Spat; Spatula, General & Plastic Surgery Bracket Obstetric Forceps INSTRUMENT CASSETTE Blood vessel forceps, Adson forceps, tissue forceps Tuning fork Otoscope MOUTH MIRROR Mayo Hegar, needle holder (Various);

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2020-11-20
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2018-10-18
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2018-10-18
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2018-10-18
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-10-18
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-10-18
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2021-12-16
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2019-12-24
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-10-18
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-05-09
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2022-12-26
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-10-18
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-10-18
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2022-12-26
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2022-12-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-11-20
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-10-18
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2019-12-24
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2021-12-16
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2019-12-24
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2018-10-18

Official Correspondent

Xia Qiu

US Agent Details

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

Related Public Records

Same Entity

Hangzhou HaiZhu MIM 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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.

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3036269993	GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD	Nanning Guangxi, CN
3029082594	CHOOSE SURGICAL INSTRUMENTS	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011585752. Last updated year: 2026. Please use registration number 3011585752 when referencing this establishment in official correspondence.