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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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LENTILLES

Certificate FR26/0000004

Rev. 1Issued
Valid until
Jan 13, 2031

Overview

Certificate number
FR26/0000004
Certificate type
Quality assurance
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1639FR26/00000041

Validity

Issued
Jan 13, 2026
Valid from
Jan 13, 2026
Valid until
Jan 13, 2031

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
Yes
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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa7

7 scopes

  • MDN1206
    Class IIa
  • MDN1206, MDS1005
    Class IIa
  • DEVICE
    Class IIa
  • Non-sterile hybrid contact lenses
    Class IIa
  • DEVICE
    Class IIa
  • Non-sterile orthokeratology contact lenses
    Class IIa
  • DEVICE
    Class IIa

Documents

LanguagesENFR

Manufacturer

Manufacturer
LENTILLES
Manufacturer SRN
FR-MF-000006721
Manufacturer country
France

Covered devices

  • 36640431B6Class IIa
    36640431B6
  • 36640433BAClass IIa
    36640433BA
  • 36640434BCClass IIa
    36640434BC