Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010611926

FEI Number

3010611926

Entity Name

TONGLU WANHE MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Building 20, Fuchun Zhichuang Park, No.516, Majia Road, Tonglu, Hangzhou Zhejiang 311504, CN

Establishment Type(s)

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

Owner / Operator

Tonglu Wanhe Medical Instrument Co., Ltd. (Owner Number: 10045600)

Owner / Operator Contact Address

Building 20, Fuchun Zhichuang Park, No.516, Majia Road, Tonglu, Hangzhou, CN-ZJ 311504, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clip remover (Thoracotomy instruments) Clamp Elevator Dissecting forceps, Grasping forceps, Suction irrigation tube, Endo bag, Veress needle, cannula Chisel (Sinuscopy instruments) Trocar Suction irrigation tube, Knot pusher, Rod, Knife, Spatula, Probe, loop, adaptor, Reducer guide bar, hook, Vaginal plate, sheath, obturator Uterine elevator, dissector, flexible forceps, Uterine manipulator, Cevical dilator Closure forceps Laryngoscopy instruments hook

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBQ	Instrument, Clip Removal	Neurology	Class 1	882.4200	2015-12-30
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-12-06
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-12-30
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-12-30
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-12-30
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2015-12-30
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2017-12-27
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-12-30
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-12-30
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2015-12-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-12-06
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-12-06
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-12-06
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-12-27
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2013-12-06
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-12-30

Official Correspondent

Zengjun Shentu

US Agent Details

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

Related Public Records

Same Entity

Tonglu Wanhe Medical Instrument 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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
2027170	MIKRON PRECISION, INC.	GARDENA, CA, US
3013784566	Berger Surgical Medical Products GmbH	Neuhausen ob Eck Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010611926. Last updated year: 2026. Please use registration number 3010611926 when referencing this establishment in official correspondence.