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Unimeditrek Pvt. Ltd. equipment is CE-marked, US FDA registered (Class I) and CDSCO registered, manufactured under ISO 9001 and ISO 13485 quality management systems. The certificate, declaration or registration document for your specific product, configuration and destination country is issued on request.
Clearances & documents, by product
| Product | ISO 9001 | ISO 13485 | CE | US FDA Registered | CDSCO | Electrical safety | Calibration | IQ/OQ/PQ | User manual | Export docs |
|---|---|---|---|---|---|---|---|---|---|---|
| Automatic Vacuum Tissue Processor | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| Automatic Slide Staining Machine | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| Tissue Embedding Station | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| Cryostat Microtome | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| Digital Tissue Floatation Bath | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| Slide Warming Table | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| Automatic Microtome | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| TissueScope LE Slide Scanner | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
| TissueScope iQ Slide Scanner | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ supplied | ✓ supplied | ✓ supplied | On request |
✓ = held / applicable across the range · ✓ supplied = provided with the instrument or on installation · On request = issued for your specific configuration and country. Certificate copies available on request. Our instruments are FDA Class I; we hold FDA establishment registration & device listing and comply with general controls.
Every claim is backed by a document
CE-marked range
Our histopathology instruments carry CE marking; the CE declaration for your product is available on request.
US FDA & CDSCO
Our instruments are FDA Class I devices for which we maintain FDA establishment registration & device listing and comply with FDA general controls; CDSCO registration applies for India. Documents on request.
ISO 9001 & ISO 13485
Designed and manufactured under certified quality management systems, with full IQ/OQ/PQ and calibration documentation.