Oneness Biotech Co., Ltd

Certificate ECM26MDR002

Rev. 0Issued

Valid until: Mar 8, 2031

Certificate ECM26MDR002 is a valid Quality management system issued to Oneness Biotech Co., Ltd and registered in EUDAMED. Valid until March 8, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: ECM26MDR002
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1282ECM26MDR0020

Validity

Issued: Mar 9, 2026
Valid from: Mar 9, 2026
Valid until: Mar 8, 2031

Manufacturer

Manufacturer: Oneness Biotech Co., Ltd
Manufacturer SRN: TW-MF-000032480
Manufacturer country: Taiwan

Notified body

Notified body
Notified body SRN: 1282
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: Yes
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

Bonvadis® Topical Cream
Class IIb

Documents

LanguagesENIT