Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014266447

FEI Number

3014266447

Entity Name

Waterpulse (Jinhua) Biotechnology Co., Ltd

City/State/Country

Yiwu City Zhejiang, CN

Establishment Address

7th Floor, Building D3-B, Yiwu High-Tech Industrial Park, No. 292 Hongru Road, Yiwu City Zhejiang 322008, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Waterpulse (Jinhua) Biotechnology Co., Ltd (Owner Number: 10056712)

Owner / Operator Contact Address

7th Floor, Building D3-B, Yiwu High-Tech Industrial Park, No. 292 Hongru Road, Yiwu City, CN-ZJ 322008, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Piercing Aftercare Fine Mist Spray, Eyelid Cleanser Water flosser (V300, V300G, V300R, V360, V600, V600G, V660, V700, V700Plus, V800) Unit, Water Flosser, Oral irrigator- Cordless water flosser (V200, V400Plus, V500, V580); Electric Toothbrush (K3, K5); Sonic Toothbrush (S6, S7, S8, S9) Nasal Aspirator (M1, M2, M3, X30, X50, X70, X90) Electric Nasal Irrigator, Nasal Irrigation Syestem (NC-3, NC-5, NA-7, NA-9) Eyelid Wipes ED-450, ED-460, ED-500, EV-400, EV-500, EV-650, ET-400, ET-500 Douche Apparatus, Vaginal, Therapeutic - Feminine Wash Bottle, Portable Bidet, Peri Bottle ED-300, ED-400, ED-400A, Saline Packets, Nasal Spray, Nasal Mist, Saline Nasal Spray, Physiological Saline

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2026-01-04
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2018-01-09
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2018-01-09
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-12-30
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2018-01-10
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2026-01-04
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2019-02-18
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2019-02-18

Official Correspondent

Yan Sun

US Agent Details

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

Related Public Records

Same Entity

Waterpulse (Jinhua) Biotechnology 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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3008646686	KIKGEL	Ujazd Opolskie, PL
8043484	Smith & Nephew Medical Ltd	HULL East Riding of Yorkshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014266447. Last updated year: 2026. Please use registration number 3014266447 when referencing this establishment in official correspondence.