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Kit O.R.L.

by LINEA STERILE S.p.A.

Ref TR315Model TRxxx(y)

Kit O.R.L. (TR315) is a Class I device made by Linea Sterile S.p.A., registered in EUDAMED on 24 Feb 2026 (Basic UDI-DI 805671184TTRTR014C), 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 Number805671184TTRTR014C Basic UDI-DI 08056711840352UDI-DIDate24 Feb 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Kit Ttr
Model / reference
TRxxx(y), TR315
Primary DI / UDI-DI
08056711840352
Basic UDI-DI
805671184TTRTR014C
EMDN code
V0599 Clinical procedures kits not included in other classes - other
Device class
Class I
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Kit sterili per procedure cliniche in tessuto tecnico riutilizzabile (TTR) - Sterile clinical procedures kits in reusable technical fabrics

Manufacturer details

EUDAMED SRN
IT-PR-000033798

Similar devices in this category

Other devices filed under CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES.

Other devices from Linea Sterile S.p.A.

See all devices from Linea Sterile S.p.A. →

Properties

  • Supplied sterile
Other properties (1, all answered No)