Jiangsu Hope Biomedical Science&Technology Co., Ltd.

Manufacturer and brand owner in Yangzhou, Jiangsu, China. 2 device types, 1 product catalogued, 2 clearances.

Registry build 21.09.26

Jiangsu Hope Biomedical Science&Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Instrument, Manual, Surgical, General Use, Electrosurgical, Cutting & Coagulation & Accessories. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.

2device types registered with the FDA
1product
2510(k) clearances

Registration

FDA registration record for Jiangsu Hope Biomedical Science&Technology Co., Ltd.
Registered name Jiangsu Hope Biomedical Science&Technology Co.,Ltd.
Status Registered
Registration expires 2026
Registration number 3016168848
FEI number 3016168848
DUNS 554490786
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Jiangsu Hope Biomedical Science&Technology Co., Ltd.
Chinese legal name 江苏昊普生物医学科技有限公司
Unified social credit code 91321012558070884M
Source NMPA UDI database

Location

Address of Jiangsu Hope Biomedical Science&Technology Co., Ltd.
City Yangzhou
Province Jiangsu
Address Building 2, No. 88, Muyang Road, High-tech Industrial Development Zone
Postal code 225127
Country China

What It Makes

Device types Jiangsu Hope Biomedical Science&Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Electrosurgical, Cutting & Coagulation & Accessories Class 2 Disposable Bipolar Forceps, Model: ZKN-3CSC, ZKN-3XSC, ZKN-3JSC, ZKN-4CSC, ZKN-4XSC, ZKN-4JSC, Disposable Bipolar Forceps, Model: ZKN-7CWC, ZKN-7XWC, ZKN-7JWC, ZKN-8CWC, ZKN-8XWC, ZKN-8JWC, Disposable Bipolar Forceps, Model: ZKN-1C, ZKN-1X, ZKN-1J, ZKN-2C, ZKN-2X, ZKN-2J, Disposable Bipolar Forceps, Model: ZKN-5CWZ, ZKN-5XWZ, ZKN-5JWZ, ZKN-6CWZ, ZKN-6XWZ, ZKN-6JWZ, Disposable Bipolar Forceps, Model: ZKN-5C, ZKN-5X, ZKN-5J, ZKN-6C, ZKN-6X, ZKN-6J, Disposable Bipolar Forceps, Model: ZKN-1CSC, ZKN-1XSC, ZKN-1JSC, ZKN-2CSC, ZKN-2XSC, ZKN-2JSC and 46 more 2023 65
Instrument, Manual, Surgical, General Use Class 1 Disposable sterile Irrigation & Suction Device, Model: CX-A1, CX-A2, CX-A3, CX-A4, CX-A5, CX-A6, CX-A7, CX-A8, Disposable sterile Irrigation & Suction Device, Model: CX-B9, CX-B10, CX-B11, CX-B12, CX-B13, CX-B14, CX-B15, Disposable sterile Irrigation & Suction Device, Model: CX-A9, CX-A10, CX-A11, CX-A12, CX-A13, CX-A14, CX-A15, Disposable sterile Irrigation & Suction Device, Model: CX-B1, CX-B2, CX-B3, CX-B4, CX-B5, CX-B6, CX-B7, CX-B8 2024 110

Own-Brand Listings

Devices catalogued by Jiangsu Hope Biomedical Science&Technology Co., Ltd.
Product Code Catalogue numbers
hoboat GEI 113

Clearances

510(k) clearances naming Jiangsu Hope Biomedical Science&Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K232703 2024-03-06 GEI Traditional This company
K231615 2023-12-05 GEI Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Jiangsu Hope Biomedical Science&Technology Co., Ltd.
Founded 2000
Factory area 100000 sq.m.
Main products neurosurgical instruments, orthopedic instruments, medical devices
Certifications FDA

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

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2,581device types they are registered for
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