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Organization name
UDI-DI code
Reference / catalog number

NeoNavia base unit — Class IIa MDR by Neonavia AB

MD Atlas
Neonavia AB

EUDAMED last updated this device on Feb 7, 2025

NeoNavia base unit

735008194NEONAVIAREUSEDE

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Neonavia AB
UDI-DI code: 17350081940031
Reference / catalog number: REF# 1102

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View device family (Basic UDI)

Manufacturer information

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

Critical warnings

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

CW999
NeoNavia® is for diagnostic use only and is not indicated for therapeutic use. NeoNavia® is contraindicated for those patients where increased risk of complications may be associated with percutaneous removal of tissue samples upon the physician’s judgment. Patients receiving anticoagulant therapy or who may have bleeding disorders may be at increased risk.
CW010
EUDAMED did not publish a description for this code.
CW999
Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection. Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, pain, and tissue adherence to the biopsy needle while removing it from the breast or axilla.
CW999
Do not use components or accessories that are not supplied or recommended by NeoNavia AB. Using improper accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the NeoNavia® biopsy system and lead to improper operation. Only connect NeoNavia® to a supply mains with protective earth. Risk of electrical shock. Do not use a multiple socket-outlet or an extension cord.
CW014
EUDAMED did not publish a description for this code.
CW999
Follow instructions for use!
CW027
Use ultrasound guidance when you operate NeoNavia®, to visualize the movements of the device. Do not use MRI or stereotactic guidance. The NeoNavia® is MR unsafe.

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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 base unit
UDI-DI code: 17350081940031
Basic UDI-DI: 735008194NEONAVIAREUSEDE
Reference / catalog number: REF# 1102
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)17350081940031

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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

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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.