Novastep S.A.S.

Certificate FR24/00000077

Rev. 8Supplemented

Valid until: Mar 21, 2029

Overview

Certificate number: FR24/00000077
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 8
Certificate ID: 1639FR24/000000778

Validity

Issued: Jun 12, 2025
Valid from: Jun 12, 2025
Valid until: Mar 21, 2029

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

FR24/00000077Quality management systemSupplementedFeb 28, 2025 → Mar 21, 2029

Scope coverage

Class IIb7Class IIa5Class I4

16 scopes

MDN1208
Class IIa
MDN1102
Class IIb
MDN1102, MDS1005
Class IIb
MDN1208
Class I
MDN1208, MDS1006
Class IIa
Reusable surgical instruments for bone preparation
Class I
Reusable surgical instruments for implantation
Class I
Reusable guides
Class I
Sterile compressive osteosynthesis staples : Arcade
Class IIb
Sterile static osteosynthesis staples
Class IIb
Non-Sterile Instruments for choice of Implants
Class IIa
Non-sterile screwdrivers for orthopaedic surgery
Class IIa
Wires for orthopaedic surgery
Class IIa
Sterile osteosynthesis screws: Nexis and PECA
Class IIb
Sterile anchorage system: AClip
Class IIb
Non-sterile osteosynthesis screw: Nexis
Class IIb

Documents

LanguagesEN

Novastep S.A.S.

Certificate FR24/00000077

Rev. 8Supplemented

Valid until: Mar 21, 2029

Overview

Certificate number: FR24/00000077
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 8
Certificate ID: 1639FR24/000000778

Validity

Issued: Jun 12, 2025
Valid from: Jun 12, 2025
Valid until: Mar 21, 2029

Manufacturer

Manufacturer: Novastep S.A.S.
Manufacturer SRN: FR-MF-000002428
Manufacturer country: France

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

FR24/00000077Quality management systemSupplementedFeb 28, 2025 → Mar 21, 2029

Scope coverage

Class IIb7Class IIa5Class I4

16 scopes

MDN1208
Class IIa
MDN1102
Class IIb
MDN1102, MDS1005
Class IIb
MDN1208
Class I
MDN1208, MDS1006
Class IIa
Reusable surgical instruments for bone preparation
Class I
Reusable surgical instruments for implantation
Class I
Reusable guides
Class I
Sterile compressive osteosynthesis staples : Arcade
Class IIb
Sterile static osteosynthesis staples
Class IIb
Non-Sterile Instruments for choice of Implants
Class IIa
Non-sterile screwdrivers for orthopaedic surgery
Class IIa
Wires for orthopaedic surgery
Class IIa
Sterile osteosynthesis screws: Nexis and PECA
Class IIb
Sterile anchorage system: AClip
Class IIb
Non-sterile osteosynthesis screw: Nexis
Class IIb

Documents

LanguagesEN