Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Manufacturer and brand owner in Cixi, Zhejiang, China. 8 device types, 7 products catalogued, 7 clearances.

Registry build 21.09.26

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Insufflator, Laparoscopic, Instrument, Ultrasonic Surgical and 6 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.

8device types registered with the FDA
7products catalogued under its own name
7510(k) clearances

Registration

FDA registration record for Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Registered name SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
Status Registered
Registration expires 2026
Registration number 3015540957
FEI number 3015540957
DUNS 550274579
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Chinese legal name 赛诺微医疗科技(浙江)有限公司
Unified social credit code 91330282MA281GXW94
Source export sales certificate, Zhejiang medical products administration

Location

Address of Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
City Cixi
Province Zhejiang
Address No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang
Postal code 315301
Country China

What It Makes

Device types Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Electrosurgical, Cutting & Coagulation & Accessories Class 2 Radio Frequency Ablation System, model: R150E, Energy Generator, Model: ES300, ES200, ES100, Electrosurgical mode of Ultrosonic Surgical & Eletrosurgical Generator, Model: SC300ES, SC200ES, SC100ES 2019 65
Instrument, Ultrasonic Surgical Class U Ultrasonic Scalpel System, Model: SC100E, Ultrasonic Surgical mode of Ultrasonic Surgical & Electrosurgical Generator, Model: SC300ES, SC200ES, SC100ES, SC200 2022 7
Insufflator, Laparoscopic Class 2 Gas Insufflator 2023 10
Laparoscope, General & Plastic Surgery Class 2 Video Endoscopy System, 3D Video Endoscopy System 2021 46
Laparoscope, Gynecologic (And Accessories) Class 2 Video Endoscopy System, 3D Video Endoscopy System 2021 7
Low Energy Direct Current Thermal Ablation System Class 2 Electroporation System (N3000) 2025 4
System, Ablation, Microwave And Accessories Class 2 Microwave Ablation System, model: M150E 2019 10
Ureteroscope And Accessories, Flexible/Rigid Class 2 Video Endoscopy System, 3D Video Endoscopy System 2021 21

Own-Brand Listings

Devices catalogued by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Product Code Catalogue numbers
Dophi GEI 20
Dophi NEY 9
Dophi OAB 8
Varicure GEI 6
DeepEye HET 6
InflaCure HIF 2

Clearances

510(k) clearances naming Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K240376 2024-10-04 OAB Traditional This company
K221995 2023-03-28 HIF Traditional This company
K212614 2022-07-18 LFL Traditional This company
K210488 2021-10-25 GEI Traditional This company
K210116 2021-10-13 HET Traditional This company
K183153 2019-07-08 NEY Traditional This company
K190052 2019-06-25 GEI Traditional This company

From the Company

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

Information published by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Founded 2015
Factory area 10000m²
Main products Ultrasonic surgical systems, Endoscopy platforms, Powered staplers, Tumor ablation systems, Energy surgery devices
Certifications CE, NMPA, FDA, ISO13485
Export markets 60+ countries in Europe, Americas, Asia, Africa

Nearby Manufacturers

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

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer