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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Self Therapy — 3 UDI-DI variants, MDR (BIO BREM SA)

MD Atlas
BIO BREM SA

Data from EUDAMED, last updated May 23, 2026

Self Therapy

7649989552Self_TherapyMB

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: BIO BREM SA

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Device characteristics

Active device

Legacy certificates

Certificate number: 0425-MDR-030113-00
Type: refdata.certificate-mdr-type.quality-assurance
Notified body: ICIM S.P.A. (0425)
Validity: Dec 20, 2024 → Dec 19, 2029

Identity & classification

Basic UDI-DI: 7649989552Self_TherapyMB
Device name: —
Device model: Self Therapy
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jan 17, 2025

Manufacturer & authorised representative

Manufacturer

Name: BIO BREM SA
SRN: CH-MF-000042028
Country: Switzerland
Email: info@biobrem.com

Authorised representative

Name: Azienda Tecnica S.r.l.
SRN: IT-AR-000039329
Country: Italy

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01JHT8T50XESYHJTVPW94TJFPF

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

STSLF0107649989552013
STENB0107649989552037
STPCK0107649989552020