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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

Neolook One — Class I MDR by Neolook Solutions

MD Atlas
Neolook Solutions

EUDAMED last updated this device on Mar 11, 2026

Neolook One

8720299NLONE6F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Neolook Solutions
UDI-DI code: 08720299947771
Reference / catalog number: ONE-PRD-401

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View device family (Basic UDI)

Manufacturer information

Organization name: Neolook Solutions
SRN: NL-MF-000028851
Manufacturer status: Active

Related devices

Neolook Compact8720299NLONE6FOn the market ONE-PRD-4018720299NLONE6FOn the market S2SFam87202999477S2SAAOn the market PRO-DIG-10087202999477S2SProfK7On 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.

Critical warnings

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

CW011
No usage in patients with open wire pacemakers or central line, unless G2 compliant

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: Neolook One
UDI-DI code: 08720299947771
Basic UDI-DI: 8720299NLONE6F
Reference / catalog number: ONE-PRD-401
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: Neolook One - Bedside Active Sensing and Imaging System, modular, 3 sensor spaces, LED illumination, PoE, Class I medical device EU MDR 2017/745, data acquisition and transmission to connected SaMD, not for standalone diagnostic use.
Additional information URL: https://www.neolooksolutions.com/
Clinical sizes: 20cm length 15cm hight 10 cm depth

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08720299947771

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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.

V80CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES

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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