ASPIRE Medical Innovation | Einsteinstraße 167 | 81677 Munich | Germany
Certificates & Documents
Marrow CellutionCERVOS KEYPRPCERVOS & Ranfac NeedlesELMI CM-7S/-8SDrucker Boost 2+MedXL CitraFlow™Elcam A-TAP™
Certificates
Manuals
Marrow Cellution:
Package Insert (multi-language): FR, GB/US, DE, ES, IT, NL, PT, DK, SE, FI, GR, PL, TR, HU, CZ
Other Documents
Product Labels:
Marrow Cellution™ MC-RAN-11C: sample label
Marrow Cellution™ MC-RAN-8C: sample label
Heparin Flush Protocol
Marrow Cellution™ component rinsing instructions & heparin concentration calculation
Declaration of Distinction
Marrow Cellution™ System vs. Standard Biopsy Needle Technology
Certificates
EU 2017/745 MDR Certificate (QM System) >> view
EC Declaration of Conformity (Aspiration Needles: RAN, MC-RAN) >> view
EC Declaration of Conformity (Biopsy Needles: RBN, RTN) >> view
ISO13485:2016 Certificate (QM System) >> view
ISO13485:2016 MDSAP Certificate (QM Conformity) >> view
US FDA Certificate to Foreign Government >> view
Documents