Erbozeta S.p.A.

Certificate 085-00-00-MDR

Rev. 00Issued

Valid until: Oct 20, 2030

Certificate 085-00-00-MDR is a valid Quality management system issued to Erbozeta S.p.A. and registered in EUDAMED. Valid until October 20, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 085-00-00-MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0426085-00-00-MDR00

Validity

Issued: Oct 21, 2025
Valid from: Oct 21, 2025
Valid until: Oct 20, 2030

Manufacturer

Manufacturer: Erbozeta S.p.A.
Manufacturer SRN: SM-MF-000031853
Manufacturer country: San Marino

Notified body

Notified body
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice
Class IIb
Sterile hypertonic saline solution for nebulization, based on N-acetylcysteine
Class IIb

Documents

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