What certifications does the anesthesia machine have?

The machine is certified with CE, FDA, and ISO13485.

Surgical Equipment Anesthesia Machine with CE

Name: Surgical Equipment Anesthesia Machine with CE
Brand: GUANGDONG HONGYANG MEDICAL EQUIPMENT LIMITED
SKU: 1964304085

Guangdong, ChinaGUANGDONG HONGYANG MEDICAL EQUIPMENT LIMITED

US$5,200.00

1-9 Pieces

US$5,000.00

10-9,999 Pieces

US$2,000.00

10,000+ Pieces

Sample price:US$5200.00/piece.Request sample

Product profile

Customization

Available

Type

Anaesthesia Machine

Kind

Surgical Instruments

Model NO.

GSM-IIIC

Certification

CE, FDA, ISO13485

Group

Adult, Children

LCD Display

With LCD Display

Warranty

1 Year

Shelf Life

3 Years

Material

Metal, Plastic

Power Source

Electricity

After-Sale Service

Online Technical Support

Component

Rack, Circuit, Vaporizer, Flow Meter, Monitor

OEM/ODM

Available

Advantage

24 Hours Playback Monitoring

Advantage 2

High Pressure Limit Alarm

Working Mode

Manual, Auto

Vaporizer

180/250ml Sevoflurane, Isoflurane, Optional

Power

220V+/-10%, 50Hz+/-1%

CO2 Absorber Capacity

Over 2L

Breathing Mode

Ippv, Sigh, Simv/F/2, Peep, Sippv

Tidal Volume

30-1500ml

Transport Package

Wooden Package

Specification

Packing Size: 84*94*162CM

Trademark

HRD

Origin

Beijing, China

HS Code

9018907000

Production Capacity

5000PCS/Month

Key features

24-Year Manufacturer Experience: Over 24 years of R&D and production experience in medical equipment.

24H Parameter Trending: Unique feature providing 24-hour whole parameter trending curves for monitoring.

High Safety Alarms: Equipped with high pressure limit alarm and hypoxia protection devices.

Multi-Certification: Certified with CE, FDA, ISO13485, and ISO9001 standards.

OEM/ODM Available: Customization services including OEM and ODM are available for clients.

Online Technical Support: Provides online technical support for after-sale service needs.

Flexible Breathing Modes: Supports IPPV, SIGH, SIMV, PEEP, and SIPPV breathing modes.

Large LCD Display: Features a 10.4-inch colorful TFT high-luminance large display.

Company profile

Importers and ExportersHigh Repeat Buyers ChoiceCustomization from DesignsR&D Capabilities

GUANGDONG HONGYANG MEDICAL EQUIPMENT LIMITED

Guangdong, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2021-09-10Nearest Port: Guangzhou HuangPuAverage Response Time: ≤5.49hTerms of Payment: T/T, PayPal, Western UnionInternational Commercial Terms(Incoterms): FOB, EXW, CFR, CIF

AI-Powered supplier vetting

SummaryThe supplier is identified as a Chinese limited company combining trading and manufacturing activities, with a valid import/export license and six employees. It reports certifications including QHSE, BSCI, ISO 14001, and ISO 9001. Product information indicates annual capacities of 1,000 anesthesia machines, 1,000 ventilators, and 5,000 vaporizers. The supplier supports multiple customization modes and reports exports to several African and Southeast Asian countries. It describes professional after-sales, installation, commissioning, and training services, with plans for more than 20 service points. Financial records are indicated for 2021–2023, but no substantive financial performance details are provided. Innovation resources appear limited by the absence of an SDK and only one stated R&D engineer, while quality-control test equipment is reported as zero.

Supplier typeThe supplier is described as a factory, trading company, and manufacturer/factory. It is a Chinese limited company located in Guangzhou, has six employees, and reports no associated company group or cooperative suppliers, indicating a small standalone operating structure.

CertificationsThe supplier reports holding QHSE, BSCI, ISO 14001, and ISO 9001 certifications. These explicitly stated certifications provide evidence of established management-system coverage, although the slices do not provide certificate scope or validity details.

After-Sales capabilityThe supplier states that it has a professional after-sales service team and installation technical engineer team, provides online and offline technical training plus installation and commissioning training, and aims to establish more than 20 service points in Africa, Southeast Asia, and the Middle East. These statements support an explicit after-sales and deployment capability.

R&D capabilityThe supplier reports one R&D engineer responsible for customer requirement confirmation, after-sales technical support, and new product development. It also explicitly reports no available SDK, while the stated total R&D engineer experience is 50 years; the limited headcount and absent SDK constrain the evidence of broader innovation capability.

Production capacityReported annual production is 1,000 anesthesia machines, 1,000 ventilators, and 5,000 vaporizers, with the same output information appearing in the production record. However, quality-control test equipment is reported as zero, which is an explicit production-quality infrastructure deficiency despite the stated capacity.

Customization capabilityThe supplier explicitly offers customization from samples, designs, full customization, minor customization, and flexible customization. Its company description also states that equipment and software can be customized according to customer needs, providing direct evidence of broad customization support.