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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

Delmont imaging

Certificate MDR-0021

Rev. 2Supplemented

Valid until: Nov 7, 2029

Overview

Certificate number: MDR-0021
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1304MDR-00212

Validity

Issued: Feb 4, 2026
Valid from: Feb 4, 2026
Valid until: Nov 7, 2029

Manufacturer

Manufacturer: Delmont imaging
Manufacturer SRN: FR-MF-000000157
Manufacturer country: France

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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: No
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

MDR-0021Quality management systemIssuedNov 8, 2024 → Nov 7, 2029

Scope coverage

Class IIb2

2 scopes

Various instruments for general and multidisciplinary surgery
Class IIb
iFlow mini
Class IIb

Documents

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