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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

NeoNavia driver — Class IIa MDR by Neonavia AB

MD Atlas
Neonavia AB

EUDAMED last updated this device on Feb 7, 2025

NeoNavia driver

735008194NEONAVIAREUSEDE

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Neonavia AB
UDI-DI code: 17350081940048
Reference / catalog number: REF# 1103

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View device family (Basic UDI)

Manufacturer information

Organization name: Neonavia AB
SRN: SE-MF-000045971
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 24, 2025	Still on market

Device identification

Trade name: NeoNavia driver
UDI-DI code: 17350081940048
Basic UDI-DI: 735008194NEONAVIAREUSEDE
Reference / catalog number: REF# 1103
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: https://neonavia.se/ifu
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)17350081940048

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

A01020199NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - 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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Related devices

NeoNavia base unit735008194NEONAVIAREUSEDEOn the market NeoNavia CorePulse probe735008194NEONAVIAPROBED2On the market NeoNavia FlexiPulse probe735008194NEONAVIAPROBED2On the market NeoNavia VacuPulse probe735008194NEONAVIAPROBED2On 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.