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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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STERYLAB S.R.L.

Certificate 012-00-01-MDR

Rev. 01Supplemented
Valid until
Feb 6, 2028

Certificate 012-00-01-MDR is a valid Technical documentation issued to STERYLAB S.R.L. and registered in EUDAMED. Valid until February 6, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
012-00-01-MDR
Certificate type
Technical documentation
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
0426012-00-01-MDR01

Validity

Issued
Mar 27, 2026
Valid from
Mar 27, 2026
Valid until
Feb 6, 2028

Notified body

Notified body
ITALCERT SRL
Notified body SRN
0426
Notified body country
Italy

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

Supersedes

  • 012-00-00-MDRTechnical documentationIssuedFeb 7, 2023 → Feb 6, 2028

Scope coverage

Unspecified1

1 scope

  • Device
    803395922DURA-JECTEA

Manufacturer

Manufacturer
STERYLAB S.R.L.
Manufacturer SRN
IT-MF-000015830
Manufacturer country
Italy

Covered devices

  • 803395922DURA-JECTEAClass III
    803395922DURA-JECTEA

Linked SSCPs

  • SSCP Annex 28 to TF 011 ST

Documents

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