Summit Medical Ltd

Certificate GB2300000400

Rev. 5Amended

Valid until: Nov 27, 2028

Certificate GB2300000400 is a valid Quality management system issued to Summit Medical Ltd and registered in EUDAMED. Valid until November 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: GB2300000400
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 1639GB23000004005

Validity

Issued: Oct 18, 2024
Valid from: Oct 18, 2024
Valid until: Nov 27, 2028

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: Others

History

Status changes

Amended

Supersedes

GB2300000400Quality management systemSupplementedOct 3, 2024 → Nov 27, 2028

Scope coverage

Class IIa9Class I4

13 scopes

Open Bowl Sterile Bone cement / bone substitute mxing system
Class IIa
Non-Sterile Bone Cement Delivery Guns
Class I
Sterile Single Use Bone Cement Mixing System - Small Port MiniMix™
Class I
Pressuriser - Sterile Bone Cement Delivery Femoral Pressuriser
Class IIa
Minimix – Sterile Bone Cement/Bone Substitute Mixing Device and Syringe (invasive)
Class IIa
MiniMix - Sterile Bone Cement/Bone Substitute Mixing Systems (SMMM1)
Class IIa
Nozzle – Sterile Bone Cement Delivery Nozzle
Class IIa
Vacuum Bowl and Accessories –Sterile Bone Cement Mixing System
Class IIa
HiVac7 – Sterile Bone Cement Mixing System
Class IIa
Mix in Syringe – Sterile Bone Cement Delivery System
Class IIa
MDN1208, MDS1006
Class I
MDN1208, MDS1005
Class I
MDN1208, MDS1005
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa9Class I4

13 scopes

Open Bowl Sterile Bone cement / bone substitute mxing system
Class IIa
Non-Sterile Bone Cement Delivery Guns
Class I
Sterile Single Use Bone Cement Mixing System - Small Port MiniMix™
Class I
Pressuriser - Sterile Bone Cement Delivery Femoral Pressuriser
Class IIa
Minimix – Sterile Bone Cement/Bone Substitute Mixing Device and Syringe (invasive)
Class IIa
MiniMix - Sterile Bone Cement/Bone Substitute Mixing Systems (SMMM1)
Class IIa
Nozzle – Sterile Bone Cement Delivery Nozzle
Class IIa
Vacuum Bowl and Accessories –Sterile Bone Cement Mixing System
Class IIa
HiVac7 – Sterile Bone Cement Mixing System
Class IIa
Mix in Syringe – Sterile Bone Cement Delivery System
Class IIa
MDN1208, MDS1006
Class I
MDN1208, MDS1005
Class I
MDN1208, MDS1005
Class IIa

Certificate GB2300000400

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate GB2300000400

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer