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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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Organization name
UDI-DI code
Reference / catalog number

2.5X — Class I MDD by Mesalvo Freiburg GmbH

MD Atlas
Mesalvo Freiburg GmbH

EUDAMED last updated this device on Oct 31, 2024

2.5X

B-04262357190001

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Mesalvo Freiburg GmbH
UDI-DI code: 04262357190001
Reference / catalog number: 2.5X

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Manufacturer information

Organization name: Mesalvo Freiburg GmbH
SRN: DE-MF-000019694
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
See IfU for details.
CW010
See IfU for details.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2022	Dec 31, 2026
Austria	Jan 1, 2022	Dec 31, 2026

Device identification

Trade name: not provided
UDI-DI code: 04262357190001
Basic UDI-DI: B-04262357190001
Reference / catalog number: 2.5X
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

Related devices

Release V / 2023.0B-04262357191046On the market Release V / 2023.3B-04262357191077On the market Release V / 2024.XX ff.B-04262357191084On the market Release V / 2023.2B-04262357191060On the market Release V / 2023.1B-04262357191053On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.