What certifications does this ECG cable have?

The product is certified with CE and ISO13485.

Original Edan ECG Defib Snap Cable 6p 5-Lead, Aha L=3.4m

Name: Original Edan ECG Defib Snap Cable 6p 5-Lead, Aha L=3.4m
Brand: Shenzhen F1 Technology Co., Ltd.
SKU: 2244297055

Guangdong, ChinaShenzhen F1 Technology Co., Ltd.

US$14.90-29.90

1 Piece

Product specifications

bag

Product profile

Customization

Available

Classification

Imaging Diagnostic Equipment

Type

ECG

Model NO.

CE05DAS061

Certification

CE, ISO13485

Weight

0.15kg

Transport Package

Neutral

Specification

13485 sgs

Trademark

Origin

Shenzhen, China

HS Code

90181930

Production Capacity

50000

Key features

OEM/ODM Support: Custom manufacturing services including OEM and ODM are welcomed for this product.

Fast Delivery: Goods are sent within 5-7 days after payment confirmation.

Multiple Shipping Options: Supports EMS, DHL, UPS, FedEx, and TNT with tracking provided.

CE and ISO13485 Certified: Product holds CE and ISO13485 certifications for quality assurance.

Flexible Payment Terms: Accepts payments via T/T and Western Union.

Company profile

Shenzhen F1 Technology Co., Ltd.

Guangdong, China

Business Type: Manufacturer/Factory, Trading CompanyAverage Response Time: ≤3.58hTerms of Payment: T/T, Western UnionInternational Commercial Terms(Incoterms): FOB, EXW

AI-Powered supplier vetting

SummaryThe supplier develops and produces electronic products and medical devices, with product offerings focused on medical monitoring cables, sensors, cuffs, and probes. It provides 3D design, OEM, ODM, and multiple customization services, supported by three R&D engineers, five quality-control test instruments, and documented design and validation records. ISO9001:2015 certification is reported. Quality inspection, supplier assessment, corrective-action, and complaint-handling procedures are documented and followed. The supplier reports repeat buyers, export activity through agents, and participation in CMEF 2024, but has no overseas warehouse, showroom, agent, or branch. Evidence of financial capacity is insufficient, and no cooperation with Fortune 500 companies or available SDK is reported.

Supplier typeThe supplier’s stated business scope covers research, development, sales, and production of electronic products and medical devices. Its listed products are specialized medical monitoring cables, sensors, cuffs, and probes, indicating a manufacturer and developer serving the medical-electronics sector.

CertificationsThe supplier reports holding an ISO9001:2015 management-system certificate and other certifications, but the specific details of the additional certifications and raw-material quality reports are not provided. The available evidence supports certification holding, although the full certification scope cannot be assessed.

After-Sales capabilityR&D engineers are responsible for technical support during production and after-sales service. The supplier also reports documented and followed procedures for customer complaints and corrective and preventive actions, but it has no overseas warehouse, showroom, agent, or branch.

R&D capabilityThe supplier reports new products during the past year, provides 3D design and ODM services, and has three R&D engineers. Design-input, output, review, verification, and validation documents are available for audit, although no SDK is available.

Production capacityThe supplier reports production of electronic products and medical devices, lists dedicated facilities including an automatic labeling facility and precision four-wire cable tester, and has five quality-control test instruments. Finished-product inspection, supplier assessment, and corrective-action procedures are documented and followed, supporting production capability.

Customization capabilityThe supplier explicitly provides customization from samples, customization from designs, full customization, minor customization, flexible customization, 3D software design services, ODM, and OEM services for popular brands. These statements provide direct evidence of broad customization capability.