i-SENS, Inc.

Certificate G10 090700 0039

Rev. Rev. 01Supplemented

Valid until: Feb 27, 2029

Certificate G10 090700 0039 is a valid Quality management system issued to i-SENS, Inc. and registered in EUDAMED. Valid until February 27, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 090700 0039
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 090700 0039Rev. 01

Validity

Issued: Jan 10, 2025
Valid from: Jan 10, 2025
Valid until: Feb 27, 2029

Manufacturer

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

G10 090700 0039IssuedFeb 27, 2024 → Feb 26, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb1

1 scope

Z12040115 - BLOOD SUGAR MONITORING SYSTEMS
Class IIb

Documents

LanguagesEN