Drillbone s.r.o.

Certificate 8801-MD-00001-24

Rev. 01Issued

Valid until: Dec 2, 2029

Certificate 8801-MD-00001-24 is a valid Quality management system issued to Drillbone s.r.o. and registered in EUDAMED. Valid until December 2, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 8801-MD-00001-24
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 13838801-MD-00001-2401

Validity

Issued: Dec 3, 2024
Valid from: Dec 3, 2024
Valid until: Dec 2, 2029

Notified body

Notified body: CESKY METROLOGICKY INSTITUT
Notified body SRN: 1383
Notified body country: Czechia

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: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I2

2 scopes

Drillbone Tunneler
Class I
Drillbone Root Repair
Class I