Medical Device Industry — Precision Die-Cutting Applications
ISO 13485 alignment and clean-grade materials; custom medical-grade die-cut parts with equal emphasis on safety and regulatory compliance.
Xinyusheng’s Core Advantages in the Medical Device Sector
Safeguarding medical safety with compliance + precision + cleanliness for diagnostic, therapeutic, and rehabilitation equipment.
Compliance Assurance
Certified to ISO 13485:2016 medical device quality management. Products meet biocompatibility and non-toxic environmental requirements.
Clean Manufacturing
Class 100,000 cleanroom production to eliminate particulate contamination and residues; high cleanliness and low particulates for medical environments.
Precision Customization
Tailored to miniaturization and high-precision trends—supports irregular, curved, and multilayer composite structures.
Quality Traceability
ERP end-to-end traceability, 100% outgoing inspection, and authority test reports available at every stage to meet high-reliability requirements.
Full-Scenario Coverage for Medical Devices
From diagnostic systems to therapeutic instruments—medical-grade die-cut solutions.
Diagnostic Equipment
Ultrasound probe seals, light-blocking parts for analyzers, sensor protection mesh, PCB insulation pads, thermal management components.
Therapeutic Devices
Protective films for surgical instruments, equipment sealing foams, conductive interconnect tabs, insulation guards, high-temperature tapes.
Rehabilitation Devices
Damping pads for prosthetic joints, seals for rehab devices, skin-contact low-irritation adhesive tapes, protective films.
Medical Consumables
One-time-use labels, packaging seals, environmentally friendly printed nameplates.
Medical-Grade Materials
Biocompatible + non-toxic + ultra-clean—comprehensively meeting medical standards.
Waterproof
Medical-grade waterproof sealing foams, sterile waterproof tapes, moisture-barrier films.
Thermal
Medical-grade thermal silicone pads, low-particulate thermal pads, high-temperature thermal sheets.
Conductive/EMI
Biocompatible conductive foam, low-contamination shielding pieces, EMI shields for medical devices.
Insulation
Medical-grade PET insulation films, PI insulation sheets, flame-retardant eco-friendly insulation foams.
Tapes
Skin-contact, low-sensitization tapes; high-temperature medical tapes; no-residue bonding tapes.
Protection
High-cleanliness protective films, low-particulate protective mesh, scratch-resistant sterile films.
Representative ClientsKey Customers in Consumer Electronics
Trusted by leading brands worldwide—quality and service proven in the field
Medical Device Die Cutting FAQs
Are your die cut medical materials certified to ISO 13485 and compliant with biocompatibility requirements?
Yes. We are certified to ISO 13485:2016. All medical-grade materials meet biocompatibility requirements. We can provide corresponding test reports and support whole-device CE/FDA certification.
Can your production environment meet the high cleanliness requirements for medical die cutting materials used in medical devices?
Absolutely. Production is in Class 100,000 cleanrooms with full dust and contamination control. Products are low-particulate and odor-free, verified by cleanliness testing for medical environments.
Do you support miniaturized, high-precision components in die cutting medical grade adhesives? What are the minimum size and accuracy?
Yes. Maximum size 1.8 × 1.2 m, minimum diameter 0.5 mm, precision ±0.03 mm. We customize micro-components for diagnostic devices and minimally invasive instruments, and already supply multiple high-precision medical die-cuts to Weitai Medical and others.
What does the cooperation process look like? Can you support long-term supply and full traceability?
Process: requirements/drawings → technical group (compliance guidance) → drawing confirmation → free samples in 1–3 days → sample testing & approval → mass production (7–20 days) → packing & delivery. We support long-term stable supply with ERP end-to-end traceability and batch test reports/records to meet medical traceability requirements.
