NTC Srl

Certificate 038-00-02-MDR

Rev. 02Withdrawn

Valid until: Jan 23, 2029

Certificate 038-00-02-MDR, a Quality management system issued to NTC Srl, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: 038-00-02-MDR
Certificate type: Quality management system
Certificate status: Withdrawn
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0426038-00-02-MDR02

Validity

Issued: Mar 14, 2025
Valid from: Mar 14, 2025
Valid until: Jan 23, 2029

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

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: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Withdrawn

Supersedes

038-00-02-MDRQuality management systemSupplementedMar 14, 2025 → Jan 23, 2029

Scope coverage

Class IIb3

3 scopes

Non-active non-implantable ophthalmologic devices
Class IIb
Ophthalmic solution with sodium hyaluronate 0,1% - 0,2% preservative free
Class IIb
Ophthalmic solution with sodium hyaluronate 0,4% preservative free
Class IIb