NTC Srl

Certificate 075-00-00-MDR

Rev. 00Withdrawn

Valid until: May 4, 2030

Certificate 075-00-00-MDR, a Quality management system issued to NTC Srl, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: 075-00-00-MDR
Certificate type: Quality management system
Certificate status: Withdrawn
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0426075-00-00-MDR00

Validity

Issued: May 5, 2025
Valid from: May 5, 2025
Valid until: May 4, 2030

Manufacturer

Manufacturer: NTC Srl
Manufacturer SRN: IT-MF-000026977
Manufacturer country: Italy

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Withdrawn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

075-00-00-MDRQuality management systemIssuedMay 5, 2025 → May 4, 2030

Scope coverage

Class IIb3

3 scopes

Non-active non-implantable ophthalmologic devices
Class IIb
Ophthalmic hypertonic ointment with Sodium hyaluronate 0.4%
Class IIb
Ophthalmic isotonic ointment with Sodium Hyaluronate 0.4%
Class IIb

Documents

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