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Support
Main Regulatory Support
Samsung Medical Rubber Co., Ltd. is responding appropriately to the various standards and requirements of customers.
Samsung Medical Rubber Co., Ltd. has registered and maintained DMF with FDA. (Registration Number: 032951)
ISO 15378 : 2017, ISO 9001 : 2015
USP CLASS VI
Minor Regulartory Support
Items for which Statements can be created
1. No metal impurities (ICH Q3D guideline)
2. Nirosoamines Free
3. Phthalate Free
4. MBT or MBCT not used
5. Latex Free
6. Compliance with REACH Annex XIV
7. Compliance with SVHC each level
8. Compliance with Califonia Proposition 65
9. Compliance with REACH Annex XVII
10. Compliance with CMR 1A & 1B
11. Asbestos not used and not contained
12. BSE/TSE Free
13. Melamine Free
14. Compliance with Regulation 10/2011/EC
15. Available as a food packaging material
16. Allergy-inducing substances not used
(Gluten, Latex, Lactose, Phthalate, etc.)
17. Heavy Metals Free"
