DELTA P S.R.L.

Certificate 063/MDR

Rev. 3Supplemented

Valid until: Nov 20, 2027

Certificate 063/MDR is a valid Quality management system issued to DELTA P S.R.L. and registered in EUDAMED. Valid until November 20, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 063/MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051063/MDR3

Validity

Issued: Jun 15, 2026
Valid from: Jun 15, 2026
Valid until: Nov 20, 2027

Manufacturer

Manufacturer: DELTA P S.R.L.
Manufacturer SRN: IT-MF-000019346
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

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

History

Status changes

Supplemented

Supersedes

063/MDRAmendedDec 5, 2024 → Nov 20, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb3Class IIa3

6 scopes

Impianti di distribuzione per gas medicali compressi e vuoto e relativi componenti / Pipeline systems for compressed medical gases and vacuum and related components
Class IIb
Impianti di evacuazione dei gas anestetici e relativi componenti / Anaesthetic gas scavenging disposal systems and related components
Class IIa
Dispositivi per gas-terapia / Devices for gas-therapy
Class IIa
Dispositivi per aspirazione medicale / Devices for medical suction
Class IIa
Riduttori di pressione per gas medicali in bombole / Pressure regulators for medical gases in cylinders
Class IIb
Centrali di alimentazione per gas medicali e relativi componenti / Supply systems for medical gases and related components
Class IIb

Documents

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