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STERIFY S.R.L.
Certificate 031-00-02-MDR
Rev. 02
Supplemented
Valid until
Oct 5, 2028
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Overview
Certificate number
031-00-02-MDR
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
3
Certificate ID
0426031-00-02-MDR02
Validity
Issued
Jan 30, 2026
Valid from
Jan 30, 2026
Valid until
Oct 5, 2028
Manufacturer
Manufacturer
STERIFY S.R.L.
Manufacturer SRN
IT-MF-000032120
Manufacturer country
Italy
Notified body
Notified body
ITALCERT SRL
Notified body SRN
0426
Notified body country
Italy
Covered devices
STERIFY GEL
Class III
80593888501W4
Characteristics
Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
No
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
No
QMS/MOS type
Basic UDI-DI data only
History
Status changes
Supplemented
Supersedes
031-00-01-MDR
Quality management system
Supplemented
May 22, 2025 → Oct 5, 2028
Scope coverage
Class III
2
2 scopes
Impianti e materiali dentali non attivi Non-active dental implants and dental materials
Class III
DEVICE
Class III
Documents
Languages
EN
IT