Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042262535

FEI Number

3042262535

Entity Name

RISUN TECHNOLOGY (SHENZHEN) LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

201, Building A, Xinmusheng Low Carbon Industrial Park, No.6 of Xinmu Road, Xinmu Community, Pinghu Street, Longgang District, Shenzhen Guangdong 518111, CN

Establishment Type(s)

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

Owner / Operator

Risun Technology (Shenzhen) Limited (Owner Number: 10094274)

Owner / Operator Contact Address

201, Building A, Xinmusheng Low Carbon Industrial Park, No.6 of Xinmu Road, Xinmu Community, Pinghu Street, Longgang District, Shenzhen, CN-GD 518111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DRX10000 Intelisonic; DRX11000; DRX11000 BH2; DRX9000 Revolation; DT-001; EKA002; EKA003 T2101; T2102; T2113; T2202; T2082S; T2030; T2030A; T2030B; T2030C; T2030D; T2030F; T2030T TB-002RIW; T100; T205601; T2209A1; T2212; T2302; T240101; T2402T; T2402C; A2980; D01B+ WITBSW5DWTRST; T2231; T2401; T2402; T2420; T2052C;T2052U; T2083; T2203A1; Z-1080 T32-OE2; T32-WE2; T33-BK2; T33-PK2; T33-WE2; T35-PK2; T35-YW2; T901; TAO Clean Sonic Toothbrush D01B Plus; D91; D93; D03B; D02B; D905; DAZ-7020; DAZ-7021; DAZ-7022; DAZ-7023; T2403; T2403A1 KATBRSHUVSA; HP107A; Atmoko; Ellesye; IRM-1; T2026; BA-0150; IT989; LHH-ETB_IB2; M2911; M2916 MT110C; M2032B; P11; P11plus; Plomo; MT110; Max Clean Sonic 5000; Mornwell A2729; Mornwell T25 GO-9301; GO-9450; GO9301; F5501; A2946; S400; S400 DELUXE; S420-BE DELUXE PLUS; S420-BK DELUXE PLUS PSP0814; R08-0018; RBH-01; RBH-8; RBH8-BE; OR3800; P9T2023; RBH8-BK; RBH8-RD; RET200 DP25288-0103; DP25289-0103; DP27146-1100; DP27146-1200; DRX-6000; DRX-6000 BH2; DRX-7000 GEHP191AP-PT; GO9450; GO9501; GS23096-1000; Healthy Clean Sonic 6000; HP-STX; HSD-008; HSD-010; HT-1 RH-250; RH-350; RS2033D; RS2082B; RS2082B Vibrite Wave; RST2710; S2,D2,K7S,E11,P11,P9,P10,E10,T9,P80,P80S WITBSW5DWTRST; XI-Sonic Kids; XI-Sonic Kids; Doodo TB001; RST2115 Umma Diamond Toothbrush with UV Sanitizer; Umma Sonic Toothbrush and Cleaning Station T2460; T26-BK1; T26; T27; T29; T27-BK1; T27-BK1; T27-WE1; T27-PK1; T27-PK1; T27-WE1; T32-GN2 SFT200; SHE037; Sonic Clean PRO 800; Shinbicare S600; T2028; T2031S; T2032; T2032A; T2032B; T2032S; T2056; T2056S; T2041 M2206,Rosa; T2072; T2076; T2080; T2081; T2082; T2082B; T2082S; T2085; T2086; BA-0101; A2090 Mornwell T37,Mornwell T37-BK1,Mornwell T37-WE1,Mornwell T38,Mornwell T38-BK1,Mornwell T38-WE1 A2767, A2768, A2769 AQLCD2, DP2, RST2030T AQP T2421D2 COSLUS C30/CX30, 711862, 5445862 Clean System; BA-0103-BLK; BA-0103-WHT; BA-0201; AQ1;T2082C; BH2OSUV001; BX-150; BX-250; BX-350; BA-0106; BA-0130 D02; D02B; D02BS; D03; D90; D901; D902; D903; D904; AQ2; DAZ-7024; DAZ-7025; DAZ-7026; DAZ-7042; DAZ-7044; DAZ-7045 HT1000; Health Tec.940-10005; Health Tec. 940-10001; HP141A; HP142A; IDDYS-1805-W1, IDDYS-1805-W1 T2203; T2205; T2206; T2207; T2209; T2209A; T2907; T2911; T2203A1; T2209; T2209B1; T2209C1 T2232; T2233; T205606; ESHP107ABUS; T205605;AMHP107AB; LA-327; M2032A,Plomo; M2206,Azul VGP-1001; VGP-1002; Vibrite PK3101; W8273; WF180W; XVR-2097; XVR-2099; XVR-2907; VP23264-3400; WITBSW5DTZBKRST RBH-7 / RST2921 /RBH-8 /RST2090 TAO Clean Sonic Toothbrush & Cleaning Station; TB-2224W; TOOTHBRUSH, POWERED; TRT500; TTP-PCOMBO-W; TTP-STB-1 S450-RD DELUXE PLUS; S450-SR DELUXE PLUS; S50; S620; S750; SA008; SB23096-0500; SB23096-1000; SB23096-4500 Triple Bristle; TTP-TB-B; TTP-TB-W; TTP-TRTB-B; TTP-TRTB-W; USAAIB2030; USAAIW2030; USAAIW2081 T2205D; T2411; T2421; T2421D2, AQP, T2421U2, AQ2P; T2421T2; AQP2; T2422; T2423, T2425 S1, S 1; T2042; T2203A1; T25; TBS28W; TBS31W; TBS40W; T205101; T2412; T2412A1; T2213 V5731; VGP-1000; Umma Diamond; Umma Diamond Sonic Toothbrush and Cleaning Station Mornwell T39; N-02, N-01, N-15, Slim, C30, CX30; NV-08093; OFI-200; OR-T50; OR-T80; OSUV001; OTR-100; PRO-40 SB23096-4600; SB27146-4500; SB27146-4600; SBS-7180; SFR201; SFR401; SFT050; SFT100; SFT150 BA-0131; BA-0132; BA-0133; BA-0134; BA-0135; BA-0139, BA-0140; BA-0150; BA-0151; BA-0152; BA-0155-WHT; BX-450; D01; D01B DAZ-7047; DAZ-7051; DAZ-7053; DAZ-7055; DAZ-7063; DAZ-7065; DAZ-7070-S; DAZ-7070-T; DAZ-7071; DAZ-7072; DAZ-7080-P T2405; T2406; T2409; T2403B3; T2272; T2422A1; T2407A1; T2460A; T2081A; T2081D; T2205A; T2205C DAZ-7081; DAZ-7142; DAZ-7144; DAZ-7145; DAZ-7147; DAZ-7180; DC-03175; DM25098-0103; DP23095-1100; DP23095-1200 S420-RD DELUXE PLUS; S430; S450 DELUXE; S450-BE DELUXE PLUS; S450-BK DELUXE PLUS Electronic Toothbrush; ES1012785; ES1014746; ES1014877; ES1014964; ER109001; EUAIB2030; EUAIW2030; EUAIW2081; FG6062 DP23096-1000; DP23264-0500; DP2; DP23264-4500; DP23264-4600; DP25098-0103; DP25104-0102; DP25105-0102 T2031; T2031B; T208302; T2117; T2117A; T2117A0; T2130; T2131; T2408; T2183; T2185, AQK1 SOC-SOT T2189 U6003; U6005; U6006; ULTRAVIOLET SANITATION/STERILIZATION; Universal Toothbrush Sterilizer COSMICSMILE; DP77180-1100; RST2937 Vibrite Wave; S1; S2; S20; S620 DELUXE; SUPERSMILE 371107; BA-0401-WHT; CVS77180-1100; D93; DP27144-1100 DP27144-1200 SB27144-1000; DT-001; EKA004; ES1012785; FG6062 RST2042; RST2043; RST2063C;; RST2072; RST2082; RST2082S; RST2918; RST2937; RST6010; RST6020; RST6021; S1 S450-BE DELUXE PLUS; S450-BK DELUXE PLUS; S450-RD DELUXE PLUS; S450-SR DELUXE PLUS SA008; SHE037; TB-002RIW; Vibrite KT6037; WITBSW5DTZBKRST; Tao Clean Germ Shield UV Sanitizer For Toothbrushes U6010 UV Sanitizer; ULTRAVIOLET SANITATION/STERILIZATION; VIO100; VIOlight Toothbrush Sanitizer LA-327;; Germ Shield; Germ Shield UV Sanitizer For Toothbrushes; RST2010; RST2011; RST2020; RST2031; RST2032; RST2032S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2025-11-20
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2025-11-20

Official Correspondent

Xander Zheng

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Risun Technology (Shenzhen) Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042262535. Last updated year: 2026. Please use registration number 3042262535 when referencing this establishment in official correspondence.