ARUM DENTISTRY Co., Ltd.

Certificate IT343738

Rev. 1Issued

Valid until: Jun 24, 2030

Certificate IT343738 is a valid Quality management system issued to ARUM DENTISTRY Co., Ltd. and registered in EUDAMED. Valid until June 24, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: IT343738
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1370IT3437381

Validity

Issued: Jun 25, 2025
Valid from: Jun 25, 2025
Valid until: Jun 24, 2030

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: 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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb8Class IIa4Class I2

14 scopes

P01020180 - DENTAL IMPLANTS - ACCESSORIES
Class IIb
Non-Sterile Zirconia Block
Class IIa
Z12110199 – INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER
Class I
P01020101 – DENTAL IMPLANTS
Class IIb
P01020180 - DENTAL IMPLANTS - ACCESSORIES
Class IIb
P01020180 - DENTAL IMPLANTS - ACCESSORIES
Class IIb
Z12110102 – DENTAL DRILLS
Class IIa
Abutment & Abutment Screw
Class IIb
Non-Sterile Zirconia Block
Class IIa
Screw Driver
Class I
Dental Implant Fixture
Class IIb
Dental Cemented Abutment
Class IIb
Dental Healing Abutment
Class IIb
Surgical Drill bits
Class IIa

Documents

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