Nirial Pharma srl

Certificate 022/MDR

Rev. 9Supplemented

Valid until: Mar 8, 2027

Certificate 022/MDR is a valid Quality management system issued to Nirial Pharma srl and registered in EUDAMED. Valid until March 8, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 022/MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051022/MDR9

Validity

Issued: Jun 30, 2026
Valid from: Jun 30, 2026
Valid until: Mar 8, 2027

Manufacturer

Manufacturer: Nirial Pharma srl
Manufacturer SRN: IT-MF-000018760
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

022/MDRSupplementedJan 16, 2026 → Mar 8, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa5Class IIb4

9 scopes

Crema destinata al trattamento topico di ferite cutanee non infette / Cream intended for topical treatment for uninfected skin wounds
Class IIa
Spray oculare / Eye spray
Class IIb
Spray criogenico per uso osteoarticolare e muscolare / Cryogenic spray for osteo-articular and muscular use
Class IIa
Gocce oculari / Eye drops
Class IIb
Spray destinato al trattamento topico di ferite cutanee non infette / Spray intended for the topical treatment of non-infected skin wounds
Class IIa
Gel per il trattamento di vaginiti, vaginosi e atrofia vaginale / Gel for the treatment of vaginitis, vaginosis and vaginal atrophy
Class IIb
Dispositivo per uso topico per il trattamento di emorroidi e ragadi anali / Device for topical use for the treatment of hemorrhoids and anal fissures
Class IIb
Soluzione spray orale per la mucosa orofaringea / Oral spray solution for oropharyngeal mucosa
Class IIa
Soluzione per irrigazione nasale in spray / Spray solution for nasal irrigation
Class IIa

Documents

LanguagesENIT