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Uno

by Dassiet Oy Finland EUDAMEDGUDID

Ref U-TACT3, U-TACT1, U-EMS1

Product code NOCEMDN M03050202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06430053264229 UDI-DIDate30 Sep 2022ListedStatusWithdrawn
European UnionCE/MDR EUDAMED Number6430053260105U Basic UDI-DIDate19 Nov 2021RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
First aid limb splint, mouldable, single-use
Model / Reference
U-TACT3 EUDAMED
U-TACT1 EUDAMED
U-EMS1 EUDAMED
U-EMS GUDID
Primary DI / UDI-DI
06430053264229, 06430053264212, 06430053264236
Basic UDI-DI
6430053260105U
FDA Product Code
NOC
EMDN Code
M03050202 Synthetic cast bandages and splints
GMDN Term
First aid limb splint, mouldable, single-use
Device Class
Class I
Regulation Number
878.3910
Market of Registration
Finland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
U-TACT3
U-TACT1
U-EMS1
GUDID
U-EMS

Manufacturer details

EUDAMED SRN
FI-MF-000016466

Related devices

Category: Cotton wool roll, sterile

Other devices from Dassiet Oy

See all devices from Dassiet Oy →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No

Sources (4)

  • EUDAMED 14ae366b-4d25-4c30-9231-1f5dead07d85 61 fields · synced 24 Oct 2026
  • EUDAMED 06430053264212|6430053260105U 61 fields · synced 18 May 2026
  • EUDAMED 06430053264236|6430053260105U 61 fields · synced 18 May 2026
  • FDA UDI bd089178-91be-4f47-a99e-91a6d64b9f68 34 fields · synced 30 May 2026