i-SENS, Inc.

Certificate V13 090700 0058

Rev. Rev. 00Supplemented

Valid until: Nov 28, 2028

Certificate V13 090700 0058 is a valid Quality management system issued to i-SENS, Inc. and registered in EUDAMED. Valid until November 28, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: V13 090700 0058
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0123V13 090700 0058Rev. 00

Validity

Issued: Feb 25, 2026
Valid from: Feb 25, 2026
Valid until: Nov 28, 2028

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: No
Human tissues: Yes
Animal tissues: Yes
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Supplemented

Supersedes

V10 090700 0045IssuedNov 29, 2023 → Nov 28, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class C2IVDR Class B1

3 scopes

IVR 0602 - Physiological markers: Specific disease
IVDR Class C
IVR 0608 - Physiological status and therapeutic measures: General physiological markers
IVDR Class B
W0101 + IVP 3012 - Clinical chemistry
IVDR Class C

Documents

LanguagesEN