Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Enraf Nonius Ultrasound Contactgel — Class I MDR by Naqi NV

MD Atlas
Naqi NV

EUDAMED last updated this device on Apr 4, 2023

Enraf Nonius Ultrasound Contactgel

542502989USUN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Naqi NV
UDI-DI code: 05425029892835
Reference / catalog number: EN US5

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Naqi NV
SRN: BE-MF-000001241
Manufacturer status: Active

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
UDI-DI code: 05425029892835
Basic UDI-DI: 542502989USUN
Reference / catalog number: EN US5
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: 5 MU02

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
Manufacturing date
Serial number
Software identification

Related devices

NAQI Cold Pack Stand in folding box & protect bag542502989CHPHROn the market CS-US500542502989USUNOn the market A Connect Gel 500 ml shipper542502989USUNOn the market Enraf Nonius Ultrasound Contactgel 250ml542502989USUNOn the market Enraf Nonius Ultrasound Contactgel bulk542502989USUNOn 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.