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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

Masimo softFlow — Class IIa MDD by TNI medical AG

MD Atlas
TNI medical AG

EUDAMED last updated this device on May 6, 2026

Masimo softFlow

B-04059163001191

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: TNI medical AG
UDI-DI code: 04059163001191
Reference / catalog number: 40610250

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Manufacturer information

Organization name: TNI medical AG
SRN: DE-MF-000006128
Manufacturer status: Active

Critical warnings

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

CW030
Not intended for life-supporting measures or invasive ventilation.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jul 1, 2021	Dec 31, 2028

Device identification

Trade name: Masimo softFlow
UDI-DI code: 04059163001191
Basic UDI-DI: B-04059163001191
Reference / catalog number: 40610250
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: High-flow nasal cannula therapy system providing heated humidified respiratory airflow for spontaneously breathing patients.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R060202OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS

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

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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.