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Documents

BIO BREM SA

Certificate 0425-MDR-030113-00

Rev. 00Suspended

Valid until: Dec 19, 2029

Certificate 0425-MDR-030113-00, a Quality assurance issued to BIO BREM SA, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-030113-00
Certificate type: Quality assurance
Certificate status: Suspended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 04250425-MDR-030113-0000

Validity

Issued: Dec 20, 2024
Valid from: Dec 20, 2024
Valid until: Dec 19, 2029

Notified body

Notified body: ICIM S.P.A.
Notified body SRN: 0425
Notified body country: Italy

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: —
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Suspended

Supersedes

0425-MDR-030113-00Quality assuranceIssuedDec 20, 2024 → Dec 19, 2029

Scope coverage

Class IIa2

2 scopes

Self Therapy
Class IIa
DEVICE
Class IIa

Manufacturer

Manufacturer: BIO BREM SA
Manufacturer SRN: CH-MF-000042028
Manufacturer country: Switzerland

Covered devices

7649989552Self_TherapyMBClass IIa
7649989552Self_TherapyMB

Documents

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