Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login
CE marked under EU MDR 2017/745 Class IIb; Notified Body: TÜV SÜD (BSI as alternative); Technical Documentation per MDR Annex II and III complete; materials: Ti-6Al-4V (femoral component), CoCrMo alloy (tibial baseplate), UHMWPE polyethylene insert (gamma-irradiated, packaged inert atmosphere), tibial stem Ti-6Al-4V; EUDAMED registration complete; UDI labelling on each component and packaging; clinical evaluation per MEDDEV 2.7/1 Rev 4 (equivalent data and literature review); 20-year clinical data from equivalent device; sterile packaging: double sterile barrier system per ISO 11607-1 and 11607-2; shelf life: 5 years; minimum 5-year product warranty; surgical instrumentation set included
ISO 13485:2016 certified (BSI, scope: orthopaedic implants manufacturing); CE MDR Class IIb certificate from TÜV SÜD (validity until 2027). EUDAMED registered. UDI implementation complete (GS1 GTIN). Currently supplying 2 Indian hospitals and 1 Singapore distributor. German hospital listing reference available from a Baden-Württemberg hospital group (Katharinenhospital). Seeking exclusive EU distributor relationship with minimum 400 sets/year commitment.