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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Medasil Surgical Limited

Certificate GB24/00000131

Rev. 2Supplemented
Valid until
Jun 13, 2029

Certificate GB24/00000131 is a valid Quality management system issued to Medasil Surgical Limited and registered in EUDAMED. Valid until June 13, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number
GB24/00000131
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
1639GB24/000001312

Validity

Issued
Sep 10, 2024
Valid from
Sep 10, 2024
Valid until
Jun 13, 2029

Notified body

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

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
Basic UDI-DI data only

History

Status changes

  • Supplemented

Supersedes

  • GB24/00000131Quality management systemIssuedJun 13, 2024 → Jun 13, 2029

Scope coverage

Class I6Class IIa3

9 scopes

  • MDN1214, MDS1005
    Class I
  • MDN1208, MDS1005
    Class IIa
  • DEVICE
    Class I
  • DEVICE
    Class I
  • DEVICE
    Class I
  • DEVICE
    Class I
  • DEVICE
    Class I
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Medasil Surgical Limited
Manufacturer SRN
GB-MF-000009549
Manufacturer country
United Kingdom

Covered devices

  • Sterile Silicone Boyle Davis Gag CoversClass I
    506046556140-11BB
  • Sterile Silicone Bite GuardsClass I
    506046556101-11A6
  • Sterile Silicone TubingClass I
    506046556261-11CM
  • Laserguard Silicone Bite GuardClass I
    506046556520-11C9
  • Laserguard Silicone Ocular ShieldClass I
    506046556510-11BW
  • Sterile Silicone Nerve Vessel LoopsClass IIa
    506046556420-11BU
  • Zoellner Suction Tip Class IIa
    506046556112-31AW