Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016458459

FEI Number

3016458459

Entity Name

Shenzhen Heearly Technology Co.,Ltd.

City/State/Country

Bao an District, Shenzhen Guangdong, CN

Establishment Address

4th Fl, Bldg B, Yangfeng Intelligent Technology Park,, Changcheng Rd, Shuitian Community, Shiyan Subdistrict, Bao an District, Shenzhen Guangdong 518108, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen Yajiebao Technology Development Co., Ltd. (Owner Number: 10062334)

Owner / Operator Contact Address

Room 607, Building 2, Sanhe International, Laiwushan New Village, Laiwushan Community, Dalang Subdistrict, Longhua District, Shenzhen, CN-GD 518108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultrasonic Cleaner T3, T3U, T5, T5U, T7, T8, T9, T10 Ultrasonic Cleaning Machine: SQ8638, SQ8639, SQ8740, SQ8750 BT-001; BT-002 Y3 Plus; Y1; Y1b; Y3; Toothbrush sterilizer: SQ8753, SQ8756 ER-200; ER-2306; ER-2308; ER-2309 Razor, Women's razor, Razor head, Electric Nose Hair Trimmer; G3, G5, G6, G7, G8 Golf Cleaning Brush: GF-001, GF-002, GF-003 CY-1913; CY-1914; CY-1915; CY-1916; CY-1917; CY-1918; CY-1919; CY-1920; CY-1921; CY-1922; CY-1923; CY-1925; CY-1928; 360E, 360F, HF160A, HF190A, HF230A, HF175, W05, W06, OC1200, HF90, YB8110, YB8130, YB8300, SQ8568, X3, P9 CY-1901; CY-1902; CY-1903; CY-1903B; CY-1904; CY-1905; CY-1906; CY-1907; CY-1908; CY-1909; CY-1910; CY-1911; CY-1912; Oral Irrigator; Water Flosser; Dental Water Jet: CY-2601, CY-2602, CY-2603, CY-2605, CY-2606, 360A, 360B, 360C, 360D, CY-2202; CY-2203; CY-2205; CY-2206; CY-2207; CY-2208; CY-2209; CY-801; CY-803; CY-201; CY-202; CY-205; CY-206; CY-820; CY-821; CY-825; CY-826; HF160A; HF175; HF176; HF190A; HF230A; W05; W05-1; W05-2; W06; OC1200 NW-300; NW-301; NW-303; NW-304; NW-304B; NW-305; NW-310; NW-318; NW-320; NW-321; NW-322; NW-323; NW-326; NW-328; NW-329; NW-330; NW-331; NW-332; HF160; HF190; HF230; HF320; HF168; HF600 Nasal Irrigation: NW-303B, PNC-01, SN-2503, 360G, 360H, 360K, HF160, HF190, HF230, HF320, HF168, HF600 TE-001; TE-002 DY-001; DY-002; DY-003; DY-004

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2026-01-14
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2025-03-14
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2025-03-14
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2025-03-14
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-03-04
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2026-01-14
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2020-01-14
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2020-01-14
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2025-03-14
JES	Floss, Dental	Dental	Class 1	872.6390	2025-03-14

Official Correspondent

Xilai Wang

US Agent Details

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

Related Public Records

Same Entity

Shenzhen Yajiebao Technology Development 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Similar Registrations

Registration Number	Establishment Name	Location
3008993611	P & T MEDICAL	Ningbo Zhejiang, CN
2518690	Keystone Industries - Delran	Delran, NJ, US
1000355982	ARMSTRONG MANUFACTURING INCORPORATED	Mississauga Ontario, CA
3007697908	Novapharm Research Australia Pty Ltd	Rosebery New South Wales, AU
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016458459. Last updated year: 2026. Please use registration number 3016458459 when referencing this establishment in official correspondence.