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Compliance · DocumentationRegulatory & Compliance Documents
We keep our regulatory claims exact. Unimeditrek Pvt. Ltd. operates ISO 9001 and ISO 13485 quality management systems. Product-specific compliance, safety and regulatory documents are provided on request for your product, configuration and destination country — because requirements differ by market. We do not display blanket country-certification badges.
What we can provide, by product
| Product | ISO 9001 | ISO 13485 | User manual | Calibration cert | IQ/OQ/PQ | Tender spec | CE (product-specific) | Electrical safety | Export documents |
|---|---|---|---|---|---|---|---|---|---|
| Automatic Vacuum Tissue Processor | ✓ QMS | ✓ QMS | ✓ supplied | ✓ supplied | ✓ supplied | On request | On request | On request | On request |
| Automatic Slide Staining Machine | ✓ QMS | ✓ QMS | ✓ supplied | ✓ supplied | ✓ supplied | On request | On request | On request | On request |
| Tissue Embedding Station | ✓ QMS | ✓ QMS | ✓ supplied | ✓ supplied | ✓ supplied | On request | On request | On request | On request |
| Cryostat Microtome | ✓ QMS | ✓ QMS | ✓ supplied | ✓ supplied | ✓ supplied | On request | On request | On request | On request |
| Digital Tissue Floatation Bath | ✓ QMS | ✓ QMS | ✓ supplied | ✓ supplied | ✓ supplied | On request | On request | On request | On request |
| Slide Warming Table | ✓ QMS | ✓ QMS | ✓ supplied | ✓ supplied | ✓ supplied | On request | On request | On request | On request |
| Automatic Microtome | ✓ QMS | ✓ QMS | ✓ supplied | ✓ supplied | ✓ supplied | On request | On request | On request | On request |
✓ QMS = covered by our ISO 9001 / ISO 13485 quality systems · ✓ supplied = provided with the instrument / on installation · On request = product-specific document issued on request for your configuration and country.
What we do not do
No blanket FDA claims
We do not display a US FDA badge. FDA status is product-specific; we state it only where a documented clearance exists.
No blanket CE/CDSCO badges
CE and CDSCO requirements are product- and market-specific. We provide the exact document for your product on request rather than a generic badge.
Exact, document-backed
Every compliance statement we make is backed by an actual document you can request and verify.