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Trialtis 5161-00-3090

by Medos International Sàrl

Ref 5161-00-3090Model TriALTIS Powered Instruments Orthopedic Surgical Drills

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002525Z Basic UDI-DI 10705034592091UDI-DIDate30 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034592091 UDI-DI Date1 Feb 2024ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Trialtis
Generic Name
Bone tap, reusable
Device Name
TriALTIS Powered Instruments Orthopedic Surgical Drills
Model / Ref / Catalog
5161-00-3090, TriALTIS Powered Instruments Orthopedic Surgical Drills, 5161003090
Primary DI / UDI-DI
10705034592091
Basic UDI-DI
0705034a002525Z
Direct Marketing DI
10705034592091
FDA Product Code
HWX
EMDN Code
Z12130599 Motorised orthopaedic surgery system instruments - other
GMDN Term
Bone tap, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Bone tap, reusable

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Reusable
  • CMR Substance
  • Measuring Function
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No