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Organization name
UDI-DI code
Reference / catalog number

Enraf Nonius Ultrasound… — Class I MDR by Naqi NV

MD Atlas
Naqi NV

EUDAMED last updated this device on Apr 4, 2023

Enraf Nonius Ultrasound Contactgel 250ml

542502989USUN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Naqi NV
UDI-DI code: 05425029892828
Reference / catalog number: EN US250

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Manufacturer information

Organization name: Naqi NV
SRN: BE-MF-000001241
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

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

CW010
Not to be used on broken skin or mucosal surfaces - External use only - Do not let applicator touch skin

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: Enraf Nonius Ultrasound Contactgel 250ml
UDI-DI code: 05425029892828
Basic UDI-DI: 542502989USUN
Reference / catalog number: EN US250
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 250 MU03

EMDN nomenclature code(s)

Z11040185ULTRASOUND SCANNERS - CONSUMABLES

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
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Software identification