ONE-PRD-401

Organization name

Neolook Solutions

SRN

NL-MF-000028851

Manufacturer status

Active

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

• CW273

  Not allowed for use with open wire pacemaker or central lines unless G2 galvanically separated and trained staff.

Primary placement in Netherlands; available across 1 country total.

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

Trade name

not provided

UDI-DI code

08720299947757

Basic UDI-DI

8720299NLONE6F

Reference / catalog number

ONE-PRD-401

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The Neolook One is a smart sensor head designed to provide continuous, high-resolution, multi-modal monitoring in neonatal and paediatric research environments. It is used to capture visual, audio and/or physiological patient data and environmental data for clinical and research use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 15 cm high, 25 cm long, 10 cm wide

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• V80CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES