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MD Atlas
Documents

DENTAL WORLD S.R.L.

Certificate IT332137

Rev. 2Supplemented

Valid until: Apr 18, 2029

Overview

Certificate number: IT332137
Certificate type: Quality assurance
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1370IT3321372

Validity

Issued: Nov 25, 2024
Valid from: Nov 25, 2024
Valid until: Apr 18, 2029

Notified body

Notified body: BUREAU VERITAS ITALIA S.P.A.
Notified body SRN: 1370
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: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

IT332137Quality assuranceIssuedApr 19, 2024 → Apr 18, 2029

Scope coverage

Class IIa4

4 scopes

MDA 0303 - Dispositivi attivi non impiantabili che utilizzano ipertermia/ipotermia
Class IIa
PRO ICE; CREA ICE; ART ICE; ZETA ICE; EXTREME ICE; DABLIU ICE; BLACK ICE; QB ICE; ICE BAG; 4-CRIO ICE; HEALY ICE;
Class IIa
FROSTLY ICE; EXPRESS ICE; GLACIER ICE; FROST ISTANT ICE; CURE ISTANT ICE; IPO ISTANT ICE; W ISTANT ICE; FREEZY ICE;
Class IIa
LUXEN ICE; CURA ICE; HELLO ICE; PRIMA ICE; ONE® – Ghiaccio istantaneo; ICE PACK
Class IIa

Documents

LanguagesIT

Manufacturer

Manufacturer: DENTAL WORLD S.R.L.
Manufacturer SRN: IT-MF-000019581
Manufacturer country: Italy