Registrations & Certifications
The registrations for our systems and processes and certifications to specific standards. This documentation is included on the applicable compliance certificates.
Labcon products in grouped classes are registered to the European IVDR 2017/746. Registered classes are EDMA Class 24 09 Micro Biology Disposables and EDMA Class 21 01 1001 CH Hardware and Assessories. Our registrar is MDI EUROPA and our registration numbers are DE/CA09/00089590 and DE/CA09/00022135.
Environmental Product Registration
Labcon products are certified to be free of any of the “listed chemicals” as referenced in the California Safe Drinking Water and Toxic Enforcement Act of 1986, (Prop 65) as revised May 25, 2018.
All our products are compliant with European Directive 2002/95/EC/-2011/65-2015/863 and contain none of the listed substances.
Our products are free of Substances of Very High Concern (SVHC) and all our products are European REACH Regulation (EC) No 1907/2006 compliant.
Our products contain resins that are either manufactured without the use bovine constituents or are processed to eliminate them during distillation. These conditions exceed the European Union standard as listed in the 22nd Commission Directive EC 98/16/EC of March 5th, 1998 as annexed to council Directive EC 76/768/EEC and further Amendment 419 Annex II of 12 June 2001, and as agreed to by the Scientific Committee on Cosmetics Recommendations concerning Tallow derivatives for processing conditions of 200ºC and 40 bars for 20 minutes. The manufacturer does not store any products of animal origin, including animal proteins, in any manufacturing areas of their facility or warehouses.
Disposables are made from 100% virgin polypropylene, polyethylene or polystyrene and are free of Oleamide and DiHEMDA processing agents.
All Labcon disposables are made from 100% virgin polypropylene, polyethylene or polystyrene and are free of Bisphenol A and Phthalates plastic processing agents.