Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011495120

FEI Number

3011495120

Entity Name

NINGBO BOLY MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

Yuyao Zhejiang, CN

Establishment Address

401, Building #4, Shengrong Micro Enterprises Park, Mazhu Town, Yuyao Zhejiang 315400, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

NINGBO BOLY MEDICAL EQUIPMENT CO., LTD. (Owner Number: 10047879)

Owner / Operator Contact Address

401, Building #4, Shengrong Micro Enterprises Park, Mazhu Town, Yuyao, CN-ZJ 315400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Small bone drill,model BL8103 Dual function Acetabulum reaming drill, model BL1204A, BL1204, BL2204 and BL1204C. Sagittal saw, model BL1102A, BL1102, BL2102, and BL1102C. Sternum saw, model BL1107A, BL1107 and BL2107. Canulate drill, model BL1101A, BL1101, BL2101, and BL1101C. Cranial Bur,model BL1106A, BL1106 and BL2106. Bone drill(1500rpm), model BL1103BA, BL1103B and BL2103B . Bone drill(1100rpm), model BL1103/AO, BL1103A, BL2103A and BL1103AC. K-wire drill,model BL8111 Small sagittal drill,model BL8102 Small canulate drill,model BL8101 Cranial drill, model BL1105A, BL1105 and BL2105. Dualfunction canulate drill, model BL1201A, BL1201, BL2201 and BL1201C Reciprocating saw, model BL1109A, BL1109 and BL2109. Acetabulum reaming drill, model BL1104A, BL1104 and BL2104. Dual function bone drill, model BL1203AA, BL1203A and BL2203A. Electric saw drill BL5813 Small K-wire Drill BL5802 Small Bone Drill BL5204 Acetabulum Reaming Drill BL5801 Small sagittal saw BL5201 Canulate Drill BL5102 Sagittal Saw BL7101 Pentype Mini drill BL5109 Reciprocating Saw BL7102 Pentype Screwdriver BL5107 Sterum Saw

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTO	Reamer	Orthopedic	Class 1	888.4540	2014-11-11

Official Correspondent

Linglong Tang

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

NINGBO BOLY MEDICAL EQUIPMENT CO., LTD.

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

View Entity Profile →

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011495120. Last updated year: 2026. Please use registration number 3011495120 when referencing this establishment in official correspondence.