Medical
Non-implantable silicone components for medical device manufacturers
SIKING in Medical
SIKING manufactures custom silicone components suitable for non-implantable medical device applications where material traceability and process control are the primary qualification requirements. All medical production uses imported LSR from Dow, Wacker ELASTOSIL, and Shin-Etsu in a Class 100K cleanroom environment.
SIKING is not a medical device manufacturer. SIKING manufactures component parts used by medical device OEMs in their finished devices. Responsibility for device-level compliance remains with the device manufacturer.
- Cleanroom: Class 100K production environment
- LSR suppliers: Dow, Wacker ELASTOSIL, Shin-Etsu — imported only
- Material traceability: batch-level, raw material to finished part
- ISO 13485: SIKING is pursuing this certification — not currently held
- ISO 9001:2015 and ISO 14001:2015 — currently held
Hearing Aid Manufacturer — Defect Reduction
SIKING's primary medical production reference. Verified outcome, no fabrication.
Key Products for Medical
Hearing Aid Components
Micro-molded LSR ear cushions, dome seals, and tubing. Sub-5mm geometry with ±0.02mm tolerance. Softness grades 15–40 Shore A for comfort-critical applications.
View Medical Silicone →Breathing Mask Components
Facial interface seals, valve diaphragms, and cushion components for respiratory masks. Soft, skin-contact grades. Material traceability documentation included.
View Medical Silicone →Diagnostic Device Seals
Sealing components for handheld and benchtop diagnostic instruments. Standard seals and O-rings produced in cleanroom environment with batch records.
View Seals →Wearable Sensor Housings
Overmolded or standalone silicone housings for skin-worn sensors and health monitoring devices. Custom geometry, color, and softness. Traceability documentation available.
View Medical Silicone →Relevant Capabilities
LSR Injection Molding
Two dedicated LSR injection units operating within the Class 100K cleanroom. Closed-mold process for contamination control. Tolerance ±0.02mm. Primary process for medical components.
Learn More →Compression Molding
Used for medical-adjacent components where LSR injection is not required. 20+ presses, dimensional inspection as standard. Batch traceability maintained.
Learn More →In-House Tooling
CNC tooling manufactured in-house for medical component molds. DFM review available before tooling commitment. 8,000+ historical molds on record.
Learn More →Medical Compliance Position
SIKING's compliance status for medical applications — stated accurately, without overclaiming.
✓ Currently Held
- ISO 9001:2015
- ISO 14001:2015
- Class 100K cleanroom production
- Imported LSR from Dow, Wacker, Shin-Etsu
- Batch-level material traceability
⚠ In Progress — Not Held
- ISO 13485 — pursuing certification
SIKING does not claim FDA compliance, ISO 10993 biocompatibility (at part level), or USP Class VI. These certifications are not held and are not claimed.
Suitable for: Non-implantable medical device components where material traceability and process control are primary requirements. For applications requiring ISO 13485, FDA QSR, or ISO 10993 part-level testing, discuss timeline and qualification plan with SIKING's engineering team.
Evaluating Suppliers for a Medical Component?
Share your component drawing and application. We'll confirm our compliance position, documentation available, and production capability — before tooling commitment.