ISO13485 Certified PCB Prototyping for Medical Device Innovations

Name: ISO13485 Certified PCB Prototyping for Medical Device Innovations
Brand: Shenzhen Tianditong Electronics Co., Ltd
SKU: 2279812975

Guangdong, ChinaShenzhen Tianditong Electronics Co., Ltd

US$1.00

5-499 Pieces

US$0.80

500-999 Pieces

US$0.70

1,000-9,999 Pieces

US$0.60

10,000+ Pieces

Product specifications

Specification

Sample price:US$0.10/piece.Request sample

Product profile

Customization

Available

Metal Coating

Gold

Mode of Production

SMT/ Thru-Hole

Model NO.

tdt-ele pcba 1027

Layers

1 - 32 Layers

Base Material

FR-4

Certification

ISO, IATF16949/QC08000/Apple Mfi

Customized

Condition

New

PCB Thickness

No Limit

PCBA Order Volume

No Limit

Layer Stackup

All Stack-up

Edge Rails

Necessary

Fiducials

Necessary

Minimum Package

1005

Minimum IC Pin Spacing

0.3mm

Minimum BGA Spacing

0.3mm

Mounting Machine

Nxt-M6III

Spi

Yes

Aoi

Yes

Visual Inspection

Yes

Function Test

Yes

Conformal Coating

Yes

PCBA Potting

Yes

Transport Package

Anti-Static Bubble Wrap ESD-Safe Blister Tray

Specification

41*40.5*30.5

Trademark

TDT-ELE

Origin

Guangdong, China

Production Capacity

50000pieces/Year

Company profile

Raw-Materials TraceabilityManagement CertificationDigital Management EnterpriseQuality Assurance

Shenzhen Tianditong Electronics Co., Ltd

Guangdong, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 21 Years CertifiedNearest Port: Shenzhen PortAverage Response Time: ≤5.13h

AI-Powered supplier vetting

SummaryThe supplier operates in electronic products, mechanical products, software, communications, environmental protection, medical products, and automation equipment, with PCBA specifically listed among its offered products. It reports comprehensive customization and ODM capabilities, recent new-product development, an available SDK, and OEM service for known brands. Production resources include SMT, reflow, wave soldering, through-hole assembly, conformal coating, glue sealing, laser cutting, and related equipment. Written procedures and records are reported for finished-product inspection, supplier-service assessment, corrective actions, and complaint handling. The supplier states that its materials meet RoHS standards. However, overseas service infrastructure is limited: it reports no overseas warehouse, showroom, agents or branches, and no participation in offline trade shows. Financial credibility and customer-case breadth cannot be fully assessed from the provided information.

Supplier typeThe supplier covers research, sales, leasing, technical consulting, and intelligent manufacturing across multiple industrial and technology categories. PCBA is explicitly listed as an offered product, while automation equipment is also within its stated business scope.

CertificationsThe supplier explicitly states that all tdt-ele materials meet the RoHS standard. No other certifications or certification documents are identified in the provided slices.

After-Sales capabilityThe supplier describes considerate after-sales service, 24-hour service, and customer-service dedication. It also reports written and followed procedures for complaint handling, corrective and preventive actions, and service-capability assessment, providing direct evidence of structured after-sales support.

R&D capabilityThe supplier reports new products within the past year, ODM service, broad design customization, and an available SDK. These points directly support active product-development and technical design capability.

Production capacityThe supplier lists PCBA among its products and identifies extensive manufacturing equipment, including SMT, reflow, wave soldering, through-hole assembly, conformal coating, glue sealing, tin management, TPT, and laser cutting systems. It also reports that finished products are inspected under written instructions that are uniformly followed.

Customization capabilityBoth slices explicitly report customization from samples and designs, full, minor, and flexible customization. The repeated evidence indicates a broad ability to support varying customer design requirements.