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SET FRESA DIAM EXGR 3.8 x 95 MM

by Prim, S.A.

Ref BAE095_38

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843404825KITFRESADOORLKY Basic UDI-DI 08434048552887UDI-DIDate26 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Agrupaciones Fresas ORL
Model / Reference
BAE095_38
Primary DI / UDI-DI
08434048552887
Basic UDI-DI
843404825KITFRESADOORLKY
EMDN Code
Q030302 ENT surgery burs and handpieces, single-use
Device Class
Class IIa
Medical Purpose
Agrupaciones de productos para cirugía de ORL que incluyen una fresa de dimensiones y material variable junto a un tubo de irrigación de bomba peristáltica

Manufacturer details

EUDAMED SRN
ES-PR-000004648

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Properties

Other properties (1)

  • Sterile: No