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SO5_FR

by dentalhitec

Ref SO5_XXModel Pack SO5

SO5_FR (SO5_XX) is a Class IIa device made by Dentalhitec, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 376034980SO5SYSTV3), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376034980SO5SYSTV3 Basic UDI-DI 03760349803225UDI-DIDate29 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
SO5
Model / reference
Pack SO5, SO5_XX
Primary DI / UDI-DI
03760349803225
Basic UDI-DI
376034980SO5SYSTV3
EMDN code
A020203 Cartridge syringes
Device class
Class IIa
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
Système d'anesthésie dentaire livré avec aiguilles

Manufacturer details

EUDAMED SRN
FR-PR-000038947

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Properties

Other properties (2, all answered No)