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ISO13485 Certified Medical PCBA with 100% E-test and UL Certified PCB Assembly

ISO13485 Certified Medical PCBA with 100% E-test and UL Certified PCB Assembly

ISO13485 Certified Medical PCBA

100% E-test PCB Assembly

UL Certified Printed Circuit Board Assembly

Place of Origin:

China or Cambodia

Brand Name:

Suntek/BLSuntek

Certification:

ISO9001 ISO13485 IATF16949 UL

Model Number:

S1025-1011

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Request A Quote
Product Details
Material::
FR4(Tg130-Tg180)/Rogers/Aluminum
Copper::
0.5OZ-10OZ
SMT,THT::
Yes
Solder Mask::
Green,Blue,Black,Red,White,Matt Color
Thickness::
1.0mm/1.6mm/2mm/4mm
RoHs::
Lead Or Lead Free
Layer::
1L-32L
Warranty::
1year
Hole Min.::
0.1mm
Payment & Shipping Terms
Minimum Order Quantity
No Limited
Price
Customized products
Packaging Details
By ESD bags and carton
Delivery Time
5-7days after all components kitted
Payment Terms
T/T
Product Description
Medical PCBA Prototype Manufacturing
100% E-test | ISO13485 | IATF 16949 | UL Certified
About Suntek Group
Suntek is a contract supplier in the EMS field providing one-stop solutions for FCB/FPC assembly, cable assembly, and box-build assembly. With facilities in Hunan Province, China and Kandal Province, Cambodia, we deliver qualified products with competitive pricing worldwide.
ISO13485 Certified Medical PCBA with 100% E-test and UL Certified PCB Assembly 0
Certified with ISO9001:2015, ISO13485:2016, IATF 16949:2016 and UL E476377, we maintain the highest quality standards across all manufacturing processes.
EMS Advantages
  • Strict product liability following IPC-A-610 standards
  • Fluent English-speaking teams for seamless communication
  • PDCA management tool implementation
  • 100% E-test and visual inspection throughout production
  • Comprehensive AOI inspection including X-ray, 3D microscope and ICT
  • High-voltage test and impedance control test capabilities
  • Multiple certifications: ISO9001, ISO13485, IATF16949 and UL
  • No minimum order quantity requirements
  • Specialization in low to medium volume production
  • Quick and on-time delivery guarantees
ISO13485 Certified Medical PCBA with 100% E-test and UL Certified PCB Assembly 1
PCB Assembly Capabilities
Item Parameter
Board Type Rigid PCB, Flexible PCB, metal core PCB, Rigid-Flex PCB
Board Shape Rectangular, Circular and any irregular Shapes
Max Size 400mm * 1200mm
Min Package 0201
Fine Pitch Parts 0.25mm
BGA Package Acceptable
DIP Capacity DIP lines and AI assembly line
Parts Sourcing All by Suntek or partial consigned by customer
Parts Package Reels, Cut Tape, Tube & Tray, Loose Parts and Bulk
Testing Visual inspection, AOI, X-RAY, Functional Testing
Types of Solder Lead or Lead-free (RoHS Compliant) assembly
Assembly Option Surface mount (SMT), Through-hole (DIP), Mixed technology
Stencils Laser cut stainless steel stencils, step-down stencil
File Formats Bill of Materials, PCB (Gerber Files), Pick-N-Place File (XYRS)
Quality Grade IPC-A-610 Class 2/Class 3
Applications
ISO13485 Certified Medical PCBA with 100% E-test and UL Certified PCB Assembly 2
Key Features
Stringent RoHS Compliance & Environmental Responsibility
Full adherence to the Restriction of Hazardous Substances (RoHS) Directive using only certified lead-free solders, substrates, and finishes. Guarantees global market access, reduces environmental impact, and ensures safe manufacturing and end-use.
Uncompromising Quality for Medical Devices
Manufactured in certified ISO 13485 quality management system with specialization in High-Density Interconnect (HDI), biocompatible materials, rigorous traceability, and high-frequency materials for precise imaging and diagnostic equipment.
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Why Choose Suntek?
As an experienced and reliable manufacturer, Suntek provides comprehensive one-stop service including PCB manufacturing and assembly. Our strong teams help customers save time and money while delivering the highest quality products at favorable prices.
Instant Quote
Receive our instant quote within 24-48 hours with positive feedback for all your project specifications.
Strong Team
Professional and experienced experts and engineers provide technical support from PCB design to turnkey PCB assembly, with prompt responses throughout the process.
Automatic Equipment
Advanced automated equipment improves working efficiency and cost effectiveness, ensuring high-quality boards at competitive prices with on-time delivery.
After Sales Service
Comprehensive order tracking with online customer service representatives providing instant updates throughout every process.
Our Support Services
We ensure cost transparency with BOM cost breakdown sharing and global component sourcing. Our structured processes include customer service procedures, RMA procedures, 8D reports, and PDCA methodology.
We respond to complaints, issues, and queries within 24 hours through weekly reports, dedicated customer support teams, and satisfaction questionnaires.
Aftersales Services
1-year guarantee period for all products, free of charge repair services, and quick compensation parts to replace defectives.
ISO13485 Certified Medical PCBA with 100% E-test and UL Certified PCB Assembly 7
Frequently Asked Questions
Q1: What files do you use in PCB fabrication?
A1: Gerber, PCB, Auto CAD
Q2: How do you make sure the quality?
A2: Our products are 100% E-tested. PCB Assembly includes 100% AOI, ICT, FT and Visual checking, plus 100% X-ray for BGA components.
Q3: Can we visit your company?
A3: Of course! Welcome to visit our company located in Xingsha Industrial Park, Changsha, Hunan province, China.
Q4: What is the lead time?
A4: 3-5 working days for samples, 7-10 working days for batch production, and 15-20 working days for PCB assembly.
Q5: Will you keep our information and files secret?
A5: Absolutely. Protecting customer designs and business secrets is our fundamental principle. NDA can be signed at any time.
Q6: How to work with you?
A6: Email us your PCB layout file and BOM list. We provide confirmation within 12 hours and quotes within 3-5 days. After price confirmation and payment terms, we proceed with your order.
We utilize advanced manufacturing equipment and technology, supported by professional engineering, purchasing, quality, and management teams to guarantee high-quality products and on-time delivery. Our products are widely used in industrial control, automotive, telecommunications, medical equipment, consumer electronics and more.
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