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UDI-DI code
Reference / catalog number

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Organization name
UDI-DI code
Reference / catalog number

STENB01 — Class IIa MDR by BIO BREM SA

MD Atlas
BIO BREM SA

Manufacturer information

Organization name: BIO BREM SA
SRN: CH-MF-000042028
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030113-00refdata.certificate-status.suspended
Quality assuranceNotified body: 0425Expiry: Dec 19, 2029

EUDAMED last updated this device on Jan 17, 2025

STENB01

7649989552Self_TherapyMB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIO BREM SA
UDI-DI code: 07649989552037
Reference / catalog number: STENB01

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Manufacturer information

Organization name: BIO BREM SA
SRN: CH-MF-000042028
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Obligation to consult the user manual

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Dec 20, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649989552037
Basic UDI-DI: 7649989552Self_TherapyMB
Reference / catalog number: STENB01
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120606MAGNETOTHERAPY EQUIPMENT

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030113-00refdata.certificate-status.suspended
Quality assuranceNotified body: 0425Expiry: Dec 19, 2029

Manufacturer information

Certificates

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STENB01

Manufacturer information

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Critical warnings

Market distribution

Device identification

Classification

Device details

EMDN nomenclature code(s)

Compliance flags

Safety

Substances

Regulatory

Lifecycle

UDI-PI traceability

Certificates