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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

1931NME — Class IIa MDD by NiniX Technologies NV

MD Atlas
NiniX Technologies NV

EUDAMED last updated this device on Feb 22, 2022

1931NME

B-BE-MF-000020369C8

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NiniX Technologies NV
UDI-DI code: D-BE-MF-000020369C8
Reference / catalog number: 1931NME

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Manufacturer information

Organization name: NiniX Technologies NV
SRN: BE-MF-000020369
Manufacturer status: Inactive

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Apr 20, 2011	Dec 31, 2024

Device identification

Trade name: not provided
UDI-DI code: D-BE-MF-000020369C8
Basic UDI-DI: B-BE-MF-000020369C8
Reference / catalog number: 1931NME
Issuing entity: EUDAMED

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: The BioniX Sim3 Pro is an apparatus intended by its manufacturer to be used specifically for diagnostic purposes in rehabilitation and intended to be used for human beings for the purpose of diagnosis, prevention and monitoring of low back pain.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Torque — 0.005 MU999

EMDN nomenclature code(s)

V0399MEASUREMENT DEVICES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

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.