MedOne Surgical, Inc.

Certificate US25/00000348 1

Rev. 1Supplemented

Valid until: Sep 1, 2030

Certificate US25/00000348 1 is a valid Quality management system issued to MedOne Surgical, Inc. and registered in EUDAMED. Valid until September 1, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: US25/00000348 1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639US25/00000348 11

Validity

Issued: Sep 1, 2025
Valid from: Sep 1, 2025
Valid until: Sep 1, 2030

Notified body

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

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: Yes
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

US25/00000348Quality management systemIssuedSep 1, 2025 → Sep 1, 2030

Scope coverage

Class IIa2

2 scopes

MDN1206, MDS1005
Class IIa
Sterile ophthalmic devices (Cannulae, brushes, picks and related accessories (tubing, backflush devices and injection kits)
Class IIa

Documents

LanguagesEN