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Symphony Oct System

by Medos International SARL 43 variants

Part of a family of 6 devices: see the family page

Ref 2020-00-154Model ‌SYMPHONY OCT INSTRUMENTS - INSTRUMENTS FOR PREPARATION

Symphony Oct System (2020-00-154) is a Class I device made by Medos International SARL, registered in EUDAMED on 17 Dec 2025 (Basic UDI-DI 0705034a002035L) and listed in FDA GUDID since 20 May 2021 (UDI-DI 10705034530642), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a002035L Basic UDI-DI 10705034530642UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034530642 UDI-DI Date20 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0705034a002035L registered 17 Dec 2025 Active
  • FDA GUDID UDI-DI 10705034530642 listed 20 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10705034530642
  2. Registered EUDAMED 0705034a002035L

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  • Withdrawn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
Symphony Oct System EUDAMED
Symphony GUDID
Generic name
Orthopaedic implantable-device cutter
Device name
‌instruments for Osteosynthesis Devices, Preparation - Symphony Oct Instruments
Model / Ref / Catalog
‌SYMPHONY OCT INSTRUMENTS - INSTRUMENTS FOR PREPARATION, 2020-00-154, 202000154
Primary DI / UDI-DI
10705034530642
Basic UDI-DI
0705034a002035L
Direct marketing DI
10705034530642
FDA product code
HTZ
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Orthopaedic implantable-device cutter
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)