Is the device certified for medical use?

Yes, it holds CE and ISO13485 certifications.

High Frequency Electrosurgical Unit Cautery (Am-S900B)

Name: High Frequency Electrosurgical Unit Cautery (Am-S900B)
Brand: Nanjing AMIS Medical Technology Co., Ltd.
SKU: 833033315

Jiangsu, ChinaNanjing AMIS Medical Technology Co., Ltd.

US$600.00-1,000.00

1 Set

Product profile

Customization

Available

Type

Surgical

Function

Tissue Repair

Model NO.

AM-S900B

Theory

Electrotherapeutics

Certification

CE, ISO13485

LCD Display

With LCD Display

Group

All

Transport Package

Carton

Specification

CE, ISO

Trademark

AMISMED

Origin

China

HS Code

94029000

Production Capacity

50000PCS/Year

Key features

Multiple Working Modes: Supports pure cut, blend 1-3, desiccate, fulgurate, spray, and bipolar modes.

High Precision Power Output: Pure cut 5-300W, Blend 1 5-240W, Blend 2 5-200W, Desiccate 5-200W, Fulgurate 5-150W, Spray 5-100W, Bipolar 2-70W.

Ultra-Low Leakage Current: Patient leakage current less than 0.01mA and ground leakage less than 0.5mA for maximum safety.

LCD Display Integration: Equipped with an LCD display for clear monitoring of working parameters.

Comprehensive Certification: Certified with CE and ISO13485 standards for medical device quality.

Complete Accessory Set: Includes active electrode, footswitch, neutral electrode, bipolar electrode, and disposable electrode.

Compact and Portable Design: Package dimensions 51x29x48cm with a gross weight of only 13kg for easy transport.

Company profile

Nanjing AMIS Medical Technology Co., Ltd.

Jiangsu, China

Business Type: Manufacturer/Factory, Trading Company, OtherAverage Response Time: ≤3.84h

AI-Powered supplier vetting

SummaryNanjing AMIS Medical Technology Co., Ltd. is a China-based limited company in Jiangsu that identifies as both a trading company and manufacturer/factory. It supplies hospital equipment, surgical products, disposables, and related medical devices, with stated exports across multiple global regions. The supplier reports ISO 13485 and ISO 9001 management-system certifications, two production lines, 6–10 R&D engineers, and 6–10 quality-control staff. It claims more than 10 years of export experience and offers stated lead times of within 15 working days in both peak and off-peak periods. Evidence supports established product, export, and quality-system capabilities, but the provided information does not sufficiently verify financial strength, customization capability, or specific customer performance cases.

Supplier typeThe supplier is identified as a limited company in China and is classified as both a trading company and manufacturer/factory. Its stated business covers manufacturing and marketing hospital equipment, surgical products, and disposable items, indicating a mixed manufacturing-and-trading operating model.

CertificationsThe supplier states that its products are certified under ISO and CE systems and specifically lists ISO 13485 and ISO 9001 management-system certifications. These statements provide explicit evidence of relevant quality and medical-device management certifications, although certificate scope and validity details are not provided.

After-Sales capabilityThe supplier explicitly promotes good after-sales service, kind service, and a long-term customer relationship, and states that it aims to provide required service and support customer success. However, no concrete service infrastructure, response times, warranty terms, or service personnel details are provided.

Production capacityThe supplier reports two production lines, 6–10 quality-control staff, more than 10 years of export experience, and stated order fulfillment within 15 working days in both peak and off-peak seasons. It also offers production-processing and inspection materials, supporting operational capability, although capacity limits and independent verification are not provided.