Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034731361

FEI Number

3034731361

Entity Name

SHENZHEN JIE BISHI TECHNOLOGY CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 1208, Xinwei Building, No. 121 Jianhui Road, Yucui Community, Longhua Street, Longhua District, Shenzhen Guangdong 518131, CN

Establishment Type(s)

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

Owner / Operator

Shenzhen Jie Bishi Technology Co., LTD (Owner Number: 10092220)

Owner / Operator Contact Address

Room 1208, Xinwei Building, No. 121 Jianhui Road, Yucui Community, Longhua Street, Longhua District,, Shenzhen, CN-GD 518131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BTJP-06, BTJP-07, BTJP-08, BTJP-09 Vaginal and anal irrigator G1,G2,B3,G4,G5,G6,G7,G8,G9,G10 W98,W99,W100,W200,W300,C3 Pro,C5 Pro,C8 Pro,C9 Pro,C2SEC3,C3PRO,C5,C5PRO,C6,C6SE,C6SE-BT,C8,C10 Ultrasound water floss Ear flushing kit W10,W20,W30,W40,W50,W60,W70,W80,W90,E10,E20,E30,E20,E50,E60,E70,E80,E90,WE100 C1,C2,C3,C4,C5,C6 Cold and hot eye protection instrument Y3.Y6,Y8,Y10,L2-1,L2-2,Y7,Y9,Y11 K1,K2,K3,K4,K5,K6 Facial Cleanser Visualization blackheads Ultrasound tooth cleaning instrument T11,T11 Pro,T11 Pro+,T12 Pro,T10,T99,T100,T200,T300,T9,T10 Pro,T12 Plus,T13,T13 Pro,T12,T20,T15,T15pr0,T18,T18pr0,T19 T19pr0,T22,T22pro E10,E20,E30,E40,E50,E60,E70,E80,E90 Hot compress steam eye cover J60,J70,J80,J90,J10,J11,J12,J13,J14,J15,J16,J17,J18,J19,J20,J30,J40,J50 otoscope water pik D60,D80,D90,D10,D11,D12,D13,D14,D15,D16,D17,D18,D20,D30,D40,D50,D70 Oral rinsing kit W98,W99,W100,W200,W300,C3 Pro,C5 Pro,C8 Pro,C9 Pro,C2SE shaver S1,S2,S3,S4,S5,S6,S7,S8,S9,S10,S11,S12,S13,S14,S15,S16,S17,S18,S19,S60,S70,S80,S90 B1,B2,B3,B5,B6,B7,B11,M1,M3,M5,M6,M7,M8,M9 Acne needle 401,402,403,408,406,I60,I70,I80,I90,I10,I11,I12,I13,I14,I15,I16,I17,I18,I19,I20 R60,R70,R80,R90,R10,R11,R12,R13,R14,R15,R16,R17,R18,R19,R20,R30,R40,R50 dental mirror Oral endoscopy Massage comb / essential oil comb S1,S2,S3,S4,S5,S6,J1,J2,J3,J4,J5,J6

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-12-15
JES	Floss, Dental	Dental	Class 1	872.6390	2024-12-15
KAO	Curette, Ethmoid	Ear, Nose, Throat	Class 1	874.4420	2024-12-15
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2024-12-15
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2024-12-15
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2024-12-15
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-12-15
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2024-12-15
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-12-15
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-12-15
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-12-15
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-12-15
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2024-12-15

Official Correspondent

Zongbin Sang

US Agent Details

jimmy chen Business: UGK-LVM UNITED INC Email: 1841621950@qq.com Phone: (323) 5104660

Related Public Records

Same Entity

Shenzhen Jie Bishi Technology 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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034731361. Last updated year: 2026. Please use registration number 3034731361 when referencing this establishment in official correspondence.