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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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MD Atlas
Documents

S.I.I.T. srl

Certificate 065-00-01-MDR

Rev. 01Supplemented

Valid until: Nov 20, 2029

Overview

Certificate number: 065-00-01-MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0426065-00-01-MDR01

Validity

Issued: Jan 21, 2026
Valid from: Jan 21, 2026
Valid until: Nov 20, 2029

Manufacturer

Manufacturer: S.I.I.T. srl
Manufacturer SRN: IT-MF-000022188
Manufacturer country: Italy

Notified body

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

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

065-00-00-MDRQuality management systemIssuedNov 21, 2024 → Nov 20, 2029

Scope coverage

Class IIb3

3 scopes

Gastrointestinal Devices
Class IIb
Kaptoflat
Class IIb
MACROGOL
Class IIb

Documents

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