01
Gels
A candidate form for soft interfaces, cushioning or encapsulation; modulus, adhesion, cure and contact boundaries remain grade-specific.
Medical-device silicone · Selection & supply
Medical-grade silicone,
specified for your device.
Start with the device application, contact nature and duration; verify the exact grade and current TDS / CoA; then coordinate samples, quotation and lot-level supply. Typical values and material-level data do not establish finished-device suitability.
- Material formGel · elastomer · LSR / HCR
- DocumentationExact grade · current TDS / CoA
- TraceabilityOrder · lot · corresponding records
- Supply pathSample → validation → production
- Exact-grade verificationNo inference from a similar code
- TDS / CoA coordinationExact grade and applicable lot
- Lot-level traceabilityOrder and delivery records govern
- Sample-to-production supplyAvailability confirmed by stage
Selection method
Four checks from device conditions to lot delivery.
Separate material screening, document review, device validation and lot delivery so each step has clear inputs and responsibilities.
- 01
Device and contact conditions
Define component location, contact nature and duration, geometry, sterilization and process.
An application category is not a material-suitability conclusion.
- 02
Exact grade and current files
Check the complete product code, material form, cure route and current TDS / CoA state.
Documentation for one grade cannot be projected onto another.
- 03
Sample and device validation
Use samples to validate processing, sterilization, compatibility and finished-device performance.
Material data does not replace finished-device evaluation.
- 04
Order and lot documents
At order and delivery, confirm the exact code, applicable lot and corresponding records.
Lot documents apply only to the delivered lot they identify.
Material families
Start with material form—do not stop at the family name.
Gels, elastomers, LSR / HCR, adhesives and coatings are screening routes. Exact selection still returns to the full product code, current files and device boundary.
Open the product catalog
02
Elastomers
A candidate form for flexible insulation, seals, membranes or molded parts; contact duration and device validation cannot be inferred from a family label.
- LSR / HCR
Narrow the route through part geometry, process, cure and validation requirements.
↗ - Adhesives, coatings and potting
Define substrates, surface treatment, film or gap before checking an exact system.
↗ - Other functional materials
Optical, low-volatility and electronic materials require their own test conditions and current files.
↗
Typical device applications
Evaluate the material inside the device architecture.
The same material form can serve a different role in each device. Define architecture, interfaces, motion, sterilization and lifecycle before discussing a grade.
- 01Neural interfaces
Flexible insulation, lead transitions and encapsulation boundaries
→ - 02Catheters & intervention
Membranes, seals, coatings and substrate interfaces
→ - 03Cochlear implants
Implant components, leads and long-term system validation
→ - 04Drug delivery
Material, drug, process and release system validated together
→ - 05Medical electronics
Potting, flexible protection and separate barrier layers
→
Documentation, evidence & lot traceability
Documentation follows the exact grade and delivered lot.
We check the current TDS against the exact product code and confirm CoA and lot records at order and delivery. Unconfirmed fields are not used for selection.
- 01Exact identity
Check the complete product code and material form
- 02Current TDS
Confirm version and applicable grade; typical values are not specifications
- 03CoA / lot
Provide and check against the applicable lot
- 04Device boundary
The device manufacturer completes finished-device evaluation and regulatory decisions
Material-level documents do not replace finished-device evaluation; CoA and lot records remain specific to the delivered lot.
Search by product code
Have a code? Start with exact identity.
Enter the complete product code to find its corresponding page. If none is available, no similar grade is substituted; open the product catalog or submit the code.
BIO technical & supply support
Support from sample review to lot-level delivery.
BIO helps device teams align product codes, required documents, samples, quotations and delivered lots.
| Legal entity | BIO Corporation · 麦法实业（上海）有限公司 |
|---|---|
| Public contact | [email protected] · +86 21 6054 7148 |
| Material & application | Review candidate grades from the device component, contact conditions, process and sterilization requirements. |
| Documents & delivery | Coordinate TDS, samples and quotations against the exact code, then confirm CoA and lot records for the delivered lot. |
Selected insights
Selected materials and regulatory insights for device teams.
FDA UDI: labeler, DI/PI, GUDID and direct-marking boundaries
Separate who is responsible, what appears on labels, what the database stores, and when direct marking is triggered.
Reviewed · 2026-07-14
Medical-device biological evaluation: a risk-based evidence route
Endpoint tables are an evaluation framework, not a test checklist; address each endpoint with evidence, testing or a sound rationale.
Reviewed · 2026-07-14
China's core medical-instrument exports: HS 9018 vs Germany and the US (2015–2024)
On one HS 9018 basis, China's 2015–2024 export CAGR was 8.52%. This is not all medical devices or global market share.
Reviewed · 2026-07-14Start an exact selection
Put device conditions, product code and document needs into one brief.
Share the device component, contact nature and duration, process or sterilization, any existing product code, expected quantity and required files. BIO can then review candidate grades, samples, quotation and lot-level supply.