NuMED, Inc.

Certificate US24/00000498

Rev. 3Supplemented

Valid until: Dec 6, 2029

Certificate US24/00000498 is a valid Quality management system issued to NuMED, Inc. and registered in EUDAMED. Valid until December 6, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: US24/00000498
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 1639US24/000004983

Validity

Issued: Mar 23, 2026
Valid from: Mar 23, 2026
Valid until: Dec 6, 2029

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

US24/00000498Quality management systemAmendedAug 5, 2025 → Dec 6, 2029

Scope coverage

Class III5

5 scopes

MDN1203, MDS1005
Class III
MDN1101, MDS1005
Class III
DEVICE
Class III
DEVICE
Class III
Sterile Covered Mounted Cheatham Platinum (CP) Stent (428.1)
Class III

Documents

LanguagesEN