BIOTEC S.R.L.

Certificate 008-00-04-MDR

Rev. 04Supplemented

Valid until: Dec 20, 2027

Certificate 008-00-04-MDR is a valid Technical documentation issued to BIOTEC S.R.L. and registered in EUDAMED. Valid until December 20, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 008-00-04-MDR
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0426008-00-04-MDR04

Validity

Issued: Mar 5, 2026
Valid from: Mar 5, 2026
Valid until: Dec 20, 2027

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

008-00-03-MDRSupplementedFeb 12, 2025 → Dec 19, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified9

9 scopes

Dental Implants
++D748CLASSICIMPWE
Zygomatic implant
++D748ZYGRHIMPLSWM
CAD-CAM Base
++D748CADCAMBASE89
Overcasting Abutments
++D748OVERALBASEAJ
Castable Plastic Abutment
++D748CASPLASABUTJ
Abutment
++D748ABUTMENTSLB
Weldable Devices
++D748WELDDEVICE58
Healing Abutment
++D748HEALIABUTMMH
Retentive Screw
++D748RETENSCREWDE

Documents

LanguagesENIT