Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027518990

FEI Number

3027518990

Entity Name

NINGBO HICREN BIOTECHNOLOGY CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Building 1& Ground Floor of Building 2, Block B, No.777, Binhai 4th Road, Hangzhou Bay New District, Ningbo Zhejiang 315336, CN

Establishment Type(s)

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

Owner / Operator

Ningbo HicRen Biotechnology Co., Ltd. (Owner Number: 10088059)

Owner / Operator Contact Address

Building 1& Ground Floor of Building 2, Block B, No.777, Binhai 4th Road, Hangzhou Bay New District, Ningbo, CN-ZJ 315336, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Location Plate Bone Drill Guide Wire Bilateral PVP/PKP Set Dilator Guidance System Percutaneous Access Needle Balloon Inflation System PCVP Set Bone Cement Delivery Cannula Bone Cement Mixing Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2023-05-21
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2024-03-02
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2023-11-16
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2023-11-16

Official Correspondent

Jia Qian

US Agent Details

Bryan Wong Business: PUREVISION AI, INC. (DBA PURE GLOBAL) Email: us-agent@pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

Ningbo HicRen Biotechnology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027518990. Last updated year: 2026. Please use registration number 3027518990 when referencing this establishment in official correspondence.