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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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LASAK s.r.o.

Certificate 2023-MDR/TD-038/A

Rev. 03Supplemented
Valid until
Oct 27, 2028

Certificate 2023-MDR/TD-038/A is a valid Technical documentation issued to LASAK s.r.o. and registered in EUDAMED. Valid until October 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
2023-MDR/TD-038/A
Certificate type
Technical documentation
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
22652023-MDR/TD-038/A03

Validity

Issued
Jun 10, 2025
Valid from
Jun 10, 2025
Valid until
Oct 27, 2028

Notified body

Notified body
3EC International a.s.
Notified body SRN
2265
Notified body country
Slovakia

Characteristics

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

History

Status changes

  • Supplemented
  • Supplemented

Supersedes

  • 2023-MDR/TD-038/ATechnical documentationIssuedJun 10, 2025 → Oct 27, 2028

Scope coverage

Unspecified13

13 scopes

  • BioniQ Prosthetic Components
    85955730009Y2
  • BioniQ Prosthetic Components
    85955730010XK
  • BioniQ Prosthetic Components
    85955730018Y3
  • BioniQ Prosthetic Components
    85955730019Y5
  • BioniQ Prosthetic Components
    85955730020XN
  • BioniQ Prosthetic Components
    85955730021XQ
  • BioniQ Prosthetic Components
    85955730022XS
  • BioniQ Prosthetic Components
    85955730023XU
  • BioniQ Prosthetic Components
    85955730024XW
  • BioniQ Prosthetic Components
    85955730025XY
  • BioniQ Prosthetic Components
    85955730026Y2
  • BioniQ Prosthetic Components
    85955730027Y4
  • BioniQ Prosthetic Components
    85955730028Y6

Documents

LanguagesCSEN

Manufacturer

Manufacturer
LASAK s.r.o.
Manufacturer SRN
CZ-MF-000031907
Manufacturer country
Czechia

Covered devices

  • BioniQ Prosthetic ComponentsClass IIb
    85955730009Y2
  • BioniQ Prosthetic ComponentsClass IIb
    85955730010XK
  • BioniQ Prosthetic ComponentsClass IIb
    85955730018Y3
  • BioniQ Prosthetic ComponentsClass IIb
    85955730019Y5
  • BioniQ Prosthetic ComponentsClass IIb
    85955730020XN
  • BioniQ Prosthetic ComponentsClass IIb
    85955730021XQ
  • BioniQ Prosthetic ComponentsClass IIb
    85955730022XS
  • BioniQ Prosthetic ComponentsClass IIb
    85955730023XU
  • BioniQ Prosthetic ComponentsClass IIb
    85955730024XW
  • BioniQ Prosthetic ComponentsClass IIb
    85955730025XY
  • BioniQ Prosthetic ComponentsClass IIb
    85955730026Y2
  • BioniQ Prosthetic ComponentsClass IIb
    85955730027Y4
  • BioniQ Prosthetic ComponentsClass IIb
    85955730028Y6