ViVitro Labs SASU
Immeuble Energie, 24-26 Boulevard Gay Lussac, Marseille, 13014, France, Marseille, France
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Register record
- A2LARefreshed
- 3224.02Active
Accredited standards
9Our reading of the A2LA scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.
ASTM F2743Name not checked yet
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; OLE1032; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1714; OLE2307
ISO 5840-1Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; OLE1032; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1714; OLE2307
ISO 5840-2Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; OLE1032; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1714; OLE2307
ISO 5840-3Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; OLE1032; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1714; OLE2307
ISO 5910Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; OLE1032; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1714; OLE2307
ISO 7198Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
ISO 25539-2; FDA Guidance 16007; OLE0811; OLE0813; ISO 7198; ISO 25539-1; OLE1215; OLE1512; OLE1513; FDA Guidance 1608; FDA Guidance 16007; FDA Guidance 1545; OLE0810; OLE0812; OLE1209; ISO 11070; OLE2209; OLE2210
ISO 11070Sterile single-use intravascular introducers, dilators and guidewires
ISO 25539-2; FDA Guidance 16007; OLE0811; OLE0813; ISO 7198; ISO 25539-1; OLE1215; OLE1512; OLE1513; FDA Guidance 1608; FDA Guidance 16007; FDA Guidance 1545; OLE0810; OLE0812; OLE1209; ISO 11070; OLE2209; OLE2210
ISO 25539-1Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
ISO 25539-2; FDA Guidance 16007; OLE0811; OLE0813; ISO 7198; ISO 25539-1; OLE1215; OLE1512; OLE1513; FDA Guidance 1608; FDA Guidance 16007; FDA Guidance 1545; OLE0810; OLE0812; OLE1209; ISO 11070; OLE2209; OLE2210
ISO 25539-2Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; OLE1032; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1714; OLE2307
ISO 25539-2; FDA Guidance 16007; OLE0811; OLE0813; ISO 7198; ISO 25539-1; OLE1215; OLE1512; OLE1513; FDA Guidance 1608; FDA Guidance 16007; FDA Guidance 1545; OLE0810; OLE0812; OLE1209; ISO 11070; OLE2209; OLE2210
Scope as published by A2LA
4 lines
ISO/IEC 17025
Active3224.02
The scope document we hold says it is valid until 2027-01-31.
Accredited scope, certificate 3224.02
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | mechanical | ISO 25539-2; ASTM F2743; AAMI TIR42; FDA guidance 1545; FDA guidance 1608; OLE1032; ISO 5840-1; ISO 5840-2; ISO 5840-3; ISO 5910; OLE1714; OLE2307 | Medical devices | -200 to 300 mmHg |
| 2 | mechanical | ISO 25539-2; FDA Guidance 16007; OLE0811; OLE0813; ISO 7198; ISO 25539-1; OLE1215; OLE1512; OLE1513; FDA Guidance 1608; FDA Guidance 16007; FDA Guidance 1545; OLE0810; OLE0812; OLE1209; ISO 11070; OLE2209; OLE2210 | - | 0.5 to 1000 cm; °C; Kg; l/min; mmHg; mm; ” |
| 3 | mechanical | - | fluids | to 10000 particles/ml |
| 4 | mechanical | - | - | - |
Ranges are reproduced from the accredited scope document as published. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
Location
Immeuble Energie, 24-26 Boulevard Gay Lussac, Marseille, 13014, France, Marseille, FR
43.29617, 5.36995
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