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Regulatory and Safety Overview
| TR HT 200 | TR 90 | GV-5H | LV-3H | |
| ISO 10993 | ✓ | ✓ | ✓ | |
| USP Class VI | ✓ | ✓ | ✓ | ✓ |
| Animal free | ✓ | ✓ | ✓ | |
| Phthalate free | ✓ | ✓ | ✓ | ✓ |
| Bisphenol free | ✓ | ✓ | ✓ | ✓ |
bio-compatibility
| TR HT 200 | TR 90 | GV-5H | LV-3H | |
| Cytotoxicity ISO 10993-5 |
✓ | ✓ | ✓ | |
| Sensitization ISO 10993-10 |
✓ | ✓ | ✓ | |
| Irritation ISO 10993-10 |
✓ | ✓ | ✓ | |
| Acute systemic toxicity ISO 10993-11 |
✓ | ✓ | ||
| Drug master file FDA | 30462 |
Here you can find our general statements and confirmation regarding "REACH" - Regulation (EC) No. 1907/2006 - and "SVHC" - "Substances of Very High Concern".
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Here you can find our general confirmations regarding "RoHS" (Restriction of Hazardous Substances) and "WEEE" (Waste Electrical and Electronic Equipment) - EU Directives 2011/65/EU and 2012/19/EU.