Basic Information
- Number
- FR22/00000038
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- July 12, 2024
- Expiry Date
- September 13, 2027
- Revision
- 8
- Manufacturer
- Newclip Technics SAS
Certificate Lifecycle
Device Characteristics
Scopes
3 scopes covering 3 risk classes
Quality Procedure Scope
Instruments used in trauma and orthopaedic surgery MDN 1208, MDS 1005, MDS 1010, MDS 1006 B-UDI : 3700569600328V, 3700569600338X, 3700569600318T, 3700569600348Z, 3700569600569B, 37005696003593, 3700569600579D, 3700569600108K, 3700569600589F, 3700569600128P, 3700569600599H, 3700569600218Q, 37005696003695, 37005696003797, 37005696003899, 3700569600399B, 3700569600408U, 37005696006092, 3700569600418W, 37005696004494
Quality Procedure Scope
Sterile and non-sterile instruments for trauma and orthopaedic surgery to be connected to active devices MDN1208 B-UDI : 3700569600679G, 37005696004698, 37005696006296, 37005696005497, 3700569600479A, 3700569600508X, 3700569600659C, 3700569600518Z, 37005696004596, 3700569600669E, 37005696006194, 37005696006398, 3700569600428Y, 37005696004392, 37005696005395, 37005696005293
Quality Procedure Scope
Implants and associated instruments for Osteosynthesis and fixation of fracture MDN1102 EMDN P09120599 : B-UDI 3700569600018J, 3700569600028L, 3700569600038N, 3700569600048Q, 3700569600068U, 37005696000992, 3700569600248W, 3700569600118M, 3700569600138R, 3700569600158V, 3700569600168X, 3700569600228S EMDN: P09120699 B-UDI: 37005696002896 EMDN: P09120601, P09120602 B- UDI: 3700569600258Y EMDN P09120599, P09120601, P09120602 B-UDI : 3700569600208N, 3700569600178Z, 3700569600148T EMDN P09120599, P09120602, P09120603 B-UDI : 37005696001995 EMDN: P09120601, P09120602, P09120603 B-UDI: 37005696001893 EMDN: P09120601, P09120602, P09120699 B- UDI : 3700569600238U EMDN: P09120599, P09120699, P09120601, P09120602 B- UDI : 3700569600078W EMDN: P09120601, P09120602, P09120603, P09120699 B- UDI : 3700569600088Y EMDN P09120601, P09120602, P09120603, P09120699 B- UDI : 37005696002794
Preceding Certificates
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.