What certifications do you hold?

We are ISO9001 certified and our products meet RoHS, CCC, and ISO13485 standards.

ISO13485 Factory Electronics 94V0 Printed Circuit Board PCBA for Medical Device

Name: ISO13485 Factory Electronics 94V0 Printed Circuit Board PCBA for Medical Device
Brand: Shenzhen Zhendatech Co., Ltd.
SKU: 2119722062

Guangdong, ChinaShenzhen Zhendatech Co., Ltd.

US$1.88-18.88

5 Pieces

Sample price:US$0.50/piece.Request sample

Product profile

Customization

Available

Metal Coating

Copper

Mode of Production

SMT

Model NO.

ZDP-1107

Layers

Multilayer

Base Material

FR-4

Certification

RoHS, CCC, ISO

Customized

Condition

New

PCBA-Testing

X-ray, Aoi

Type

Rigid Circuit Board

Processing Technology

Electrolytic Foil

Insulation Materials

Organic Resin

Flame Retardant Properties

Transport Package

Packed with ESD Protection in Carton

Specification

Flexible base on drawing required

Trademark

ZD/OEM/ODM/CUSTOM

Origin

Shenzhen, China

HS Code

8473409001

Production Capacity

100 000 PCS/Month

Key features

ISO13485 Certified Factory: Manufacturing facility certified for medical device production standards.

Customized PCBA Solutions: Full OEM/ODM services with customizable layers, materials, and coatings.

Comprehensive Testing: Includes 100% E-Test, X-Ray, AOI, ICT, FCT, and aging tests.

Fast Response Time: Inquiries replied within 24 hours; quotes provided in 24-48 hours.

Wide Material Selection: Offers FR-4, Halogen-free, High TG, PTFE, Aluminum, and Rogers boards.

Flexible Surface Finishes: Available options include HASL, OSP, ENIG, Immersion Gold, and Gold Finger.

High Precision Specs: Minimum line width/space 0.076mm with tight tolerances on dimensions.

Company profile

Shenzhen Zhendatech Co., Ltd.

Guangdong, China

Business Type: Manufacturer/Factory, Trading Company, Group CorporationExport Year: 2013-08-01Nearest Port: Shenzhen portAverage Response Time: ≤15hTerms of Payment: LC, T/T, D/P, etc.International Commercial Terms(Incoterms): FOB, CFR, CIF, FAS, DDP, DAP, CIP, FCA, EXW

AI-Powered supplier vetting

SummaryShenzhen Zhendatech Co., Ltd. is a China-based limited company identified as a trading company, manufacturer/factory, and group corporation. It was established in 2005 and provides PCBA/PCB assembly, cable and wire harness assembly, sheet-metal fabrication, kiosk and order-machine OEM/ODM, product assembly, LED industrial lighting, and related turnkey services. The supplier reports more than 150 employees, over 6,000 square meters of factory space, more than 10 production lines, and annual productivity of 360,000 pieces for its listed product categories. It holds TS 16949, ISO 9001, and QC 080000 certifications. Its stated capabilities include PCB manufacturing up to 64 layers, 0201 component placement, BGA spacing down to 0.3 mm, and SPI, AOI, ICT, FCT, X-ray, RoHS, and aging inspections. The supplier exports to multiple regions and reports cooperation experience with European and North American clients. Evidence is insufficient to assess financial credibility, innovation capability, and specific...

Supplier typeThe supplier is explicitly classified as a trading company, manufacturer/factory, and group corporation, with a limited-company ownership structure. This indicates a mixed manufacturing and trading profile rather than a purely commercial intermediary.

CertificationsThe supplier reports holding TS 16949, ISO 9001, and QC 080000 management-system certifications. These certifications provide explicit evidence of formal quality, automotive-related quality, and hazardous-substance management systems.

After-Sales capabilityThe supplier states that it has warehouses in Hong Kong, Europe, and North America, can prepare boards near customers, and can provide Kanban service according to customer requirements. It also offers testing, final assembly, conformal coating, and peripheral-product support, but the slices do not describe a formal warranty or complaint-resolution policy.

R&D capabilityThe supplier offers electronic product design as part of its turnkey services and reports technical PCB capabilities including up to 64 layers, 0201 placement, and 0.3 mm BGA spacing. These facts demonstrate engineering and process capability, but they do not establish a broader record of proprietary innovation or new-product development.

Production capacityThe supplier reports more than 10 production lines, over 150 employees, a factory exceeding 6,000 square meters, 360,000 pieces of annual productivity for its listed categories, and order fulfillment within 15 working days in both peak and off-peak seasons. Its stated inspection coverage includes SPI, AOI, ICT, FCT, X-ray, RoHS, and aging, supporting a substantial production and quality-control capability.

Customization capabilityThe supplier provides PCB assembly across SMT, DIP, MI, and AI processes, component procurement, product final assembly, testing, conformal coating, electronic product design, sheet-metal fabrication, cable and wire harness assembly, and kiosk/order-machine OEM/ODM. This broad turnkey and OEM/ODM offering is explicit evidence of customization capability across multiple product stages.

Client casesThe supplier states that it has 10 years of cooperation experience with European and North American clients and mentions companies such as Xilinx, TI, Avnet, and Future. However, the slices do not specify project scope, order history, references, or independently verifiable case details, so the evidence supports customer exposure but not a fully documented case record.