FILMAR S.r.l.

Certificate 0425-MDR-030065-00

Rev. 00Withdrawn

Valid until: Jan 24, 2029

Certificate 0425-MDR-030065-00, a Quality assurance issued to FILMAR S.r.l., has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-030065-00
Certificate type: Quality assurance
Certificate status: Withdrawn
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 04250425-MDR-030065-0000

Validity

Issued: Jan 25, 2024
Valid from: Jan 25, 2024
Valid until: Jan 24, 2029

Notified body

Notified body: ICIM S.P.A.
Notified body SRN: 0425
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: 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: Others

History

Status changes

Withdrawn

Supersedes

0425-MDR-030065-00Quality assuranceIssuedJan 25, 2024 → Jan 24, 2029

Scope coverage

Class IIa3

3 scopes

Bende con pasta all'ossido di zinco elastiche e anelastiche. Elastic and inelastic zinc oxide paste bendages.
Class IIa
BENDA ANAELASTICA “PRONTOZINK” / ANAELASTIC BANDAGE “PRONTOZINK”
Class IIa
BENDA ELASTICA “PRONTOZINK ELASTIC” e “PRONTOZINK BI ELASTIC” / ELASTIC BANDAGE “PRONTOZINK ELASTIC” and “PRONTOZINK BI ELASTIC”
Class IIa