Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005980667

FEI Number

3005980667

Entity Name

NINGBO RAFFINI IMPORT & EXPORT CO., LTD

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No168, Changshou East Road, Yinzhou District, Ningbo Zhejiang 315000, CN

Establishment Type(s)

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

Owner / Operator

Ningbo Raffini Import & Export Co., Ltd (Owner Number: 10061858)

Owner / Operator Contact Address

No168, Changshou East Road, Yinzhou District, Ningbo, CN-ZJ 315000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electric Toothbrush TONGUE SCRAPER Teething Ring, Ring, Teething, Fluid-Filled 53oz/15 grams all natural homeopathic formula citroganix soothing gel with silicone gume-eez teether Nail Clipper Nipple, Lambs Feeding Dental floss Non-fluid filled silicone teether; Ring, Teething, Non-Fluid Filled Nasal aspirator Rechargeable Microdermabrasion Device Tape Foot file Hair & Scalp electric massager hot & cold eye mask Electric Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2021-06-25
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2021-05-12
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2019-11-25
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-11-15
FNN	Nipple, Lambs Feeding	General Hospital	Class 1	880.5640	2021-11-10
JES	Floss, Dental	Dental	Class 1	872.6390	2023-09-22
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2020-12-29
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2022-09-13
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2020-04-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-07-23
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-11-10
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-02-23
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2022-07-10
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2021-06-25

Official Correspondent

Dennis Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Ningbo Raffini Import & Export 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3029987245	FLAUS, INC.	New York, NY, US
3013257234	MINGZHEN (DONGGUAN) ELECTRONICS CO., LTD	Dongguan Guangdong, CN
3038200340	WEIFANG YANGXU LABOR PROTECTION PRODUCTS CO., LTD	Weifang Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005980667. Last updated year: 2026. Please use registration number 3005980667 when referencing this establishment in official correspondence.