Independent Verification
SGS Tested & Verified
Independent Material Reports
Third-Party Testing • Material Safety Verification • Global Compliance
ISO13485 Certified • FDA Registered • CE Approved OEM/ODM Factory
Accredited Independence
SGS Testing Partnership
Furuize commissions SGS for independent material and product verification on menstrual cups and discs — accredited third-party reports that pharmacy buyers, notified bodies, and importers require alongside in-house lot-release testing.
- • Chemical, biocompatibility, and mechanical panels per SKU risk class
- • Triggered on new materials, mold launches, and annual surveillance
- • ISO 13485 sampling with chain-of-custody to ISO/IEC 17025 labs
- • Factory lab for daily SPC; SGS for regulatory-grade attestation
- • Report index under document control — supports CE and FDA files
Test Matrix
Material & Product Test Items
Test scope scales with device risk and destination market — Furuize maintains a rolling SGS test catalog for medical-grade LSR, cured plaques, and finished cups/discs, selecting subsets per project.
SGS Test Matrix
Panels selected per SKU risk class and destination market
Raw Material & Chemical Compliance
RoHS, REACH SVHC screening, heavy metals (Pb, Cd, Hg, Cr VI), phthalate and PAH limits, volatile organic compound headspace on cured silicone.
Biocompatibility & Biological Evaluation
ISO 10993 endpoints commissioned at SGS when notified-body or US dossier depth requires third-party execution: cytotoxicity, sensitization, irritation/intracutaneous reactivity.
Food-Contact & Migration Analogs
FDA 21 CFR indirect food-additive frameworks and EU migration analogs where retailers request extractable profiles beyond biocompatibility minimums.
Physical & Mechanical Performance
Tensile strength, elongation at break, tear resistance, hardness (Shore A), and compression set on cured plaques and production cups.
Thermal & Aging Stability
Heat resistance and accelerated aging after repeated boil-cycle conditioning — supporting IFU reprocessing claims and shelf-life rationale.
Packaging & Ancillary Articles
Selected tests on retail cartons, pouches, and printed inks when private-label packaging programs bundle packaging sourced through Furuize.
Report Library
Latest Test Reports
Report categories on file
Base LSR chemical compliance, biocompatibility panels, mechanical property certificates, migration/extractable studies, and packaging material safety addenda — each with a "current valid" flag tied to material-change triggers.
Refresh cadence & triggers
Annual surveillance re-tests core chemical panels on production lots; event-driven refresh within thirty days of pigment supplier switch, catalyst ratio adjustment, or new mold steel commissioning.
OEM access & redaction
Brand owners receive PDF copies or authenticated summaries under NDA — sufficient for Amazon vendor central uploads, EU technical-file annexes, and investor data rooms.
Verification & anti-fraud
Procurement teams verify report authenticity directly with SGS — we supply report numbers, issue dates, and lab location metadata for confirmation.
Certification integration
CE technical files cite SGS reports in Annex II sections; FDA dossiers attach biocompat summaries; ISO 13485 design files index report numbers in verification trace matrices.
Global Shipment
Export Compliance Support
Documentation bundles per destination
EU-bound containers attach SGS chemical and biocompatibility summaries to commercial invoices; US shipments pair SGS reports with FDA establishment registration references and lot-coded COAs.
Customs & border risk reduction
Export coordinators cross-check SGS report metadata against packing lists before ex-factory release — third-party SGS branding carries weight with customs inspectors.
OEM private-label export paths
Export packs support factory-direct FOB shipments and co-branded report covers when your brand name must appear on certificates submitted to retail vendor portals.
Reactive support & re-testing
Border holds or retailer requests for supplemental testing escalate through the SGS partnership queue with priority turnaround on defined method subsets.
Standard export packet
Commercial invoice, packing list with lot numbers, certificate of analysis, SGS test report copies indexed to shipped lots, and MSDS where carriers require.
SGS Testing & Compliance FAQ
What does SGS testing cover for menstrual cups?
Raw material compliance, biocompatibility analogs, mechanical performance, thermal aging, and migration screening — summarized per SKU family.
Can I receive SGS reports for vendor onboarding?
Report indexes and redacted samples available via compliance inquiry during due diligence.
How do SGS results connect to in-house testing?
Factory testing lab runs ongoing lot validation; SGS provides independent third-party attestation for retail buyers.
Are SGS reports updated when materials change?
Material or pigment changes trigger change control and updated test protocols under ISO 13485 before mass release.
Related Compliance & OEM Resources
Certifications & Testing
Manufacturing & Launch
SGS Tested Menstrual Cups for Global Markets
Contact us to get SGS reports and OEM/ODM product specifications.