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Neolook One

by Neolook Solutions

Ref ONE-PRD-401Model Neolook One

Neolook (ONE-PRD-401) is a medical device (EU MDR Class I; EMDN category clinical use accessories not included in other classes) made by Neolook Solutions, registered in EUDAMED on 7 Mar 2026 (Basic UDI-DI 8720299NLONE6F), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8720299NLONE6F Basic UDI-DI Date7 Mar 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
Neolook One, ONE-PRD-401
Primary DI / UDI-DI
08720299947757, 08720299947771
Basic UDI-DI
8720299NLONE6F
Direct marketing DI
08720299947771
EMDN code
V80 Clinical use accessories not included in other classes
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000028851

Similar devices in this category

Other devices filed under CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Neolook Solutions

Properties

Other properties (14, all answered No)