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R1 Dental Sensor

by iRay Group

Ref 03160151-002Model Pluto0000X

R1 Dental Sensor (03160151-002) is a Class IIa device made by iRay Group, registered in EUDAMED on 5 Feb 2024 (Basic UDI-DI 697056909INTRAORALSR7E), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697056909INTRAORALSR7E Basic UDI-DI 06970569091037UDI-DIDate5 Feb 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Digital intraoral X-ray imaging system
Model / reference
Pluto0000X, 03160151-002
Primary DI / UDI-DI
06970569091037
Basic UDI-DI
697056909INTRAORALSR7E
Direct marketing DI
06970569091037
EMDN code
Z11030402 Systems for intraoral digital videoradiography
Device class
Class IIa
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000037606
Authorised representative
iRay Europe GmbH DE-AR-000007525

Similar devices in this category

Other devices filed under SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY.

Other devices from iRay Group

See all devices from iRay Group →

Properties

Other properties (14, all answered No)