Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015532203

FEI Number

3015532203

Entity Name

CHAMFOND BIOTECH CO., LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

2/F,Bldg E,Sino-Danish Eco life Science Park, Jiangbei New Area, Nanjing Jiangsu 210032, CN

Establishment Type(s)

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

Owner / Operator

Chamfond Biotech Co., Ltd (Owner Number: 10060786)

Owner / Operator Contact Address

2/F,Bldg E,Sino-Danish Eco life Science Park, Jiangbei New Area, Nanjing, CN-JS 210032, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Binocular Loupes goggle Face Shield Face shield Hooks mask Retractor Reusable Retractor Rings

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2019-06-24
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-02-27
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-02-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2021-02-25
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-06-24
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-23
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-06-24

Official Correspondent

No official correspondent registered.

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Chamfond Biotech 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
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

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.

Similar Registrations

Registration Number	Establishment Name	Location
3027499529	VISUSCIENCE MEDITECH CO., LTD.	WUXI Jiangsu, CN
3004095674	BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.	SAO CARLOS Sao Paulo, BR
3014683120	JMU DENTAL, INC	Fullerton, CA, US
9680411	HOSPITAL EQUIPMENT MFG. CO.	NOIDA Uttar Pradesh, IN
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015532203. Last updated year: 2026. Please use registration number 3015532203 when referencing this establishment in official correspondence.