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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

Innoventa Medica ApS

Certificate 28620145188

Rev. 00Issued

Valid until: Mar 20, 2028

Overview

Certificate number: 28620145188
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862014518800

Validity

Issued: Mar 21, 2023
Valid from: Mar 21, 2023
Valid until: Mar 20, 2028

Manufacturer

Manufacturer: Innoventa Medica ApS
Manufacturer SRN: DK-MF-000013980
Manufacturer country: Denmark

Notified body

Notified body: Intertek Medical Notified Body AB
Notified body SRN: 2862
Notified body country: Sweden

Covered devices

Lecigon PEG J, ENFitClass IIb
5745000321LecigonPEGJET

Characteristics

Sterile: No
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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

- Jejunostomy tubes - Gastrostomy tubes
Class IIb
DEVICE
Class IIb

Documents

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