Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026766126

FEI Number

3026766126

Entity Name

CHANGZHOU CENTRAU MEDICAL INSTRUMENT CO.,LTD.

City/State/Country

CHANGZHOU Jiangsu, CN

Establishment Address

No.5,Hexiang Road,Wujin Economic Development Zone,Changzhou,Jiangsu,China, CHANGZHOU Jiangsu 213000, CN

Establishment Type(s)

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

Owner / Operator

Changzhou Centrau Medical Instrument Co.,Ltd. (Owner Number: 10087164)

Owner / Operator Contact Address

No.5,Hexiang Road,Wujin Economic Development Zone,Changzhou,Jiangsu,China, CHANGZHOU, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Forceps - Plate Cutter; Reduction Forceps With Points; Reduction Forceps With Serrated Jaws; Rod Bender; Rod Holding Forceps; Rod Rotation Forceps; Vise Grip Pliers; Wire Cutter Tap,Bone Reamer Broach; Rasp Hip Instrument set Posterior Cervical Instrument Set Orthopedic Manual Surgical Instrument-Anterior Cervical Instrument Set Knee Instrument set Cannulated screw instrument set Endoscope Instrument Set for Spine Lumbar Cage Instrument Set Locking Nail Instrument set Torque Handle Spine Minimally Invasive System Instrument Set Plate and Screw Fix Instrument set Curette Dental Instrument set Spine System Instrument Set Ratchet handle,Quick Change handle, Trial Countersink Passer,wire,orthopedic Bit,Drill bit Bone Mill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2023-01-20
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-01-20
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-01-20
HTQ	Broach	Orthopedic	Class 1	888.4540	2023-01-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-01-19
HWW	Countersink	Orthopedic	Class 1	888.4540	2023-01-20
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2023-01-20
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2023-01-20
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2023-01-20

Official Correspondent

Hongmei Zhou

US Agent Details

Jason Zhou Email: ShamrockIE49@hotmail.com Phone: (626) 6325067

Related Public Records

Same Entity

Changzhou Centrau 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
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-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

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3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3003675041	SURGICAL INSTRUMENTS BELGIUM SA	GEMBLOUX Namur, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026766126. Last updated year: 2026. Please use registration number 3026766126 when referencing this establishment in official correspondence.