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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

Navina™ Classic System Small Refill — Class I MDR

MD Atlas
Wellspect HealthCare

EUDAMED last updated this device on Mar 25, 2025

Navina™ Classic System Small Refill

733338724104D3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Wellspect HealthCare
UDI-DI code: 07333387027159
Reference / catalog number: 6900881

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View device family (Basic UDI)

Manufacturer information

Organization name: Wellspect HealthCare
SRN: SE-MF-000026271
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 2 countries total.

Country	On market since	Until
SwedenPrimary placement		Still on market
Portugal		Still on market

Device identification

Trade name: Navina™ Classic System Small Refill
UDI-DI code: 07333387027159
Basic UDI-DI: 733338724104D3
Reference / catalog number: 6900881
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Transanal Irrigation System (TAI). Includes: 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal balloon catheters.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

G020199GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER

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

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