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Elos Instruments SE218

by Intrauma SpA

Ref SE218Model str.003

Elos Instruments SE218 is a device classified as Class IIa in the EU and Class II in the US made by Intrauma SpA, registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI B-08056693001857), cleared under FDA 510(k) K201147 on 19 Jul 2021 and listed in FDA GUDID since 20 Oct 2023 (UDI-DI 08056693001857), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201147

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08056693001857 Basic UDI-DI 08056693001857UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056693001857 UDI-DI Date20 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201147 Date19 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08056693001857 registered 2 Oct 2026 Active
  • FDA 510(k) K201147 decided 19 Jul 2021 Active
  • FDA GUDID UDI-DI 08056693001857 listed 20 Oct 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201147
  2. Listed FDA GUDID 08056693001857
  3. Registered EUDAMED B-08056693001857

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Diaphyseal Screw Guide EUDAMED
Elos Instruments GUDID
Generic name
Orthopaedic implantation sleeve, reusable
Model / Ref / Catalog
SE218, str.003
Primary DI / UDI-DI
08056693001857
Basic UDI-DI
B-08056693001857
510(k) Number
FDA product code
HSB
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Orthopaedic implantation sleeve, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08056693001857: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic implantation sleeve, reusable

Cleared under the same submission (K201147)

and 8 more cleared under K201147

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Intrauma SpA

See all devices from Intrauma SpA →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)