Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030535035

FEI Number

3030535035

Entity Name

ANQING CHANGFAN MEDICAL INSTRUMENT CO., LTD

City/State/Country

Anqing Anhui, CN

Establishment Address

Building 7, Huqian Industrial Park, Qianshan Development Zone, Anqing Anhui 246300, CN

Establishment Type(s)

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

Owner / Operator

Anqing Changfan Medical Instrument Co., Ltd (Owner Number: 10089838)

Owner / Operator Contact Address

Building 7, Huqian Industrial Park, Qianshan Development Zone, Anqing, CN-AH 246300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Otoscope ENT AND Accessories Lavage Jet Led Light Source endoscopic, Portable Led Light Source, USB Portable Led Light Source, Changfan 4K Endoscope Camera, HD 1080P Endoscope Camera, Portable Endoscope Camera Unit, Portable USB Endoscope Camera, Changfan arthroscopic devices Changfan 35 Knotless PEEK CF Push-In Suture Anchor Driver 45 Knotless PEEK CF Push-In Suture Anchor Driver 8 Point Drill Guide various instruments punches forceps accessories ENT Nasal Laryngoscopy, Punches, Forceps, Rongeur, RASP, Curette, Probe, Changfan Gastro-Urology Instruments Rigid and Flexible Forceps, Scissors, and Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2025-12-10
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-08-21
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2024-01-12
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-01-12
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2024-01-12
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-01-12
FHB	Hook, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2025-12-10

Official Correspondent

Joseph .

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Anqing Changfan 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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3030089857	Nordes Sp. z o.o.	Wroclaw Dolnoslaskie, PL
9614434	STORZ ENDOSKOP PRODUKTIONS GMBH	SCHAFFHAUSEN, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030535035. Last updated year: 2026. Please use registration number 3030535035 when referencing this establishment in official correspondence.