Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008615394

FEI Number

3008615394

Entity Name

NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD

City/State/Country

NANNING Guangxi, CN

Establishment Address

7th FLOOR, GENERAL BUILDING,, HETAI SCI.&TECH. PARK,9 GAOXIN 4th RD, NANNING Guangxi 530007, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD (Owner Number: 10049130)

Owner / Operator Contact Address

7th FLOOR, GENERAL BUILDING,, HETAI SCI.&TECH. PARK,9 GAOXIN 4th RD, NANNING, CN-GX 530007, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultrasonic Scaler, P7,B5,B5S,B5L,P4,P5,P5L,B6,B6S,B6L,P6,P7L,P9,P9L,C5,C5S,C5L,C6,C7,C7L BD2 CD1; CD2 ;CD3 P9-2 RH1,RHS,RH2,RH3,RL1,RL3,RD1,RD2,RD3,RP1,RP2,RP3,RP4,RP5 K10 P8L,MPT1 GL5,GL5L Face Shield (Model: FS-A) Face Shield (Model: FS-B) Non-surgical Mask Extraoral suction system model: ESS1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2015-04-17
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-05-06
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-23
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2020-05-14

Official Correspondent

Wanqing Bi

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

NANNING BAOLAI 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
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06

Similar Registrations

Registration Number	Establishment Name	Location
3042256012	QUANZHOU AGURU E-COMMERCE CO., LTD	Quanzhou Fujian, CN
1052939	Medidenta	Las Vegas, NV, US
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3003933619	MECTRON S.P.A.	CARASCO Genova, IT
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008615394. Last updated year: 2026. Please use registration number 3008615394 when referencing this establishment in official correspondence.